December 17, 2012-Tranzyme
Pharma's DIGEST Trial Stopped for Futility After Interim Analysis of the Phase 2b Results
RESEARCH TRIANGLE PARK, N.C., Dec. 17, 2012 (GLOBE NEWSWIRE)
-- Tranzyme Pharma (Nasdaq:TZYM) today announced it is discontinuing and immediately ending patient enrollment in DIGEST,
a Phase 2b trial in diabetic patients receiving TZP-102 for the management of symptoms of gastroparesis, due to insufficient
efficacy. The decision followed a planned interim futility analysis, which examined patients' responsiveness to thrice daily
oral dosing of 10mg of TZP-102 or placebo at the end of weeks 4 and 8 of a 12 week trial. The results are consistent with
the findings of a prior Phase 2b trial in that there was a very large placebo effect and no treatment effect.
August 9, 2012-Company Completes Patient Enrollment in TZP-102 Phase2b
Trial
RESEARCH TRIANGLE PARK, N.C., Aug. 9, 2012 (GLOBE
NEWSWIRE) -- Tranzyme Pharma (Nasdaq:TZYM), a biopharmaceutical company focused on discovering, developing and commercializing
novel, first-in-class small molecule therapeutics for the treatment of gastrointestinal (GI) motility disorders, today announced
its financial results and business update for the second quarter ended June 30, 2012.
"We are very pleased that patient enrollment in our 12-week Phase 2b trial evaluating TZP-102
for diabetic gastroparesis is complete, and we are on target to announce top-line study results by year-end," said Vipin K.
Garg, Ph.D., President and CEO of Tranzyme Pharma. "Diabetic gastroparesis affects millions of people worldwide, yet there
are no safe and effective treatments available to them. With the incidence of diabetes on the rise, it is expected that the
prevalence of gastroparesis in these patients will rise correspondingly."
Recent Developments
TZP-102 Phase 2b Trial Enrollment Completion
The Company recently completed patient enrollment in the Phase 2b 12-week trial
of its first-in-class, oral, gastrointestinal (GI) motility drug candidate, TZP-102. The trial is being conducted in patients
suffering from diabetic gastroparesis, a chronic, often life-altering GI condition affecting both type 1 and type 2 diabetic
patients. Preliminary top-line data are expected by year-end 2012.
October 5, 2011-Tranzyme Pharma Initiates Dosing in Phase 2b Trial of TZP-102 in Diabetic
Patients With Gastroparesis
Tranzyme Pharma (Nasdaq:TZYM), today announced that it has dosed its first patient in a
Phase 2b, 12-week trial of its first-in-class, oral, gastrointestinal (GI) motility drug candidate, TZP-102. The trial will
be conducted in patients suffering from diabetic gastroparesis, a chronic, often life-altering GI condition affecting both
type 1 and type 2 diabetic patients. The Company expects to dose approximately 200 patients in the U.S. and Europe across
three treatment arms: 10mg or 20mg doses of TZP-102 or placebo.
"Given the limited treatment options for the large population of people with diabetes suffering
from gastroparesis, there is a critical need for a safe and effective treatment," said Steven Cliff, M.D. of Arkansas Gastroenterology
in Sherwood, AR, the first study site to begin enrollment. "Gastroparesis can cause serious complications and has the potential
to exacerbate diabetes symptoms because it can lead to erratic digestion and fluctuating blood sugar levels. We are enthusiastic
about the potential of TZP-102 as it could represent a significant advancement in the treatment of gastroparesis."
TZP-102 represents a novel mechanism of action as it targets the ghrelin receptor, which
plays a direct role in the stimulation of GI motility. TZP-102 is an orally-administered promotility agent in clinical development
for the treatment of diabetic gastroparesis. Currently, there are no safe and effective treatments for gastroparesis. In recognition
of this critical unmet need, the Food and Drug Administration (FDA) has granted TZP-102 Fast Track designation.
"We are very pleased that patient enrollment in the TZP-102 Phase 2b trial is underway according
to plan," said Vipin Garg, Ph.D., President and CEO, Tranzyme Pharma. "We remain committed to developing a safe and effective
therapy that reduces the severity of symptoms and improves the daily lives of patients suffering from gastroparesis, as well
as other GI motility disorders that impact millions of patients worldwide."
The Phase 2b trial is a double-blind, multinational evaluation of two dose levels of TZP-102
and placebo administered orally, once daily, for 12 weeks in diabetic patients with a history of moderate to severe symptoms
of gastroparesis. Study subjects will report symptom severity daily. Top-line data are expected by year-end 2012.
A 28-day Phase 2 trial of TZP-102 in this same patient population demonstrated statistically
and clinically significant improvements for each of the most prevalent symptoms of gastroparesis: nausea, early satiety, bloating
and upper abdominal pain. In addition, the results concluded TZP-102 was effective in both type 1 and type 2 diabetics, safe
and well tolerated.
Tranzyme Pharma to Present Additional Phase 2 Data of Oral GI Motility Agent
TZP-102 Showing Improvement of Debilitating Symptoms in Patients with Diabetic Gastroparesis
May 10, 2011- Tranzyme Pharma (Nasdaq:TZYM), a clinical-stage biopharmaceutical company,
will present Phase 2 data of TZP-102, an orally-administered ghrelin agonist in development for diabetic gastroparesis, an
upper gastrointestinal (GI) motility disorder, during a poster session at Digestive Disease Week (DDW). Tranzyme released
the 28-day trial's positive top-line results in June, 2010; findings from additional analyses are set forth in the poster
which will be on display Tuesday, May 10, 2011 from 12:00 P.M. to 2:00 P.M. CT in Hall A at McCormick Place.
The 18 center, multinational trial involved 92 diabetic patients with delayed gastric emptying
and moderate to severe symptoms of gastroparesis, who were randomized to receive 10, 20 or 40mg of TZP-102 or a placebo for
28 days. Efficacy was measured by improvement in patient-reported symptoms and Overall Treatment Effect scale. While all three
TZP-102 doses tested were effective, the most positive responses were achieved at 20mg, with no additional benefit observed
at the 40mg dose. At the end of the treatment period, statistically and clinically significant improvements were observed
for each of the most prevalent symptoms for this patient population: nausea, early satiety, postprandial fullness, bloating
and upper abdominal pain. In addition, the patient-reported Overall Treatment Effect score was significantly better for TZP-102-treated
patients vs. placebo-treated patients. The correlation between improvement in individual symptoms and patient's overall satisfaction
with treatment was strong and highly statistically significant.
All doses of TZP-102 were well-tolerated and safe as indicated by adverse events, vital
signs, electrocardiograms and laboratory parameters. These include no changes in body weight or any parameters of glucose
control in this diabetic patient population.
"TZP-102 represents a promising advance in the treatment of diabetic gastroparesis," said
Richard McCallum, MD, FACP, FRACP (AUST), FACG, Professor & Chairman of Medicine at Texas Tech University Health Sciences
Center, Paul L. Foster School of Medicine. "Despite the fact that this chronic condition affects an estimated 20 million individuals
worldwide, no adequate treatment options for diabetic gastroparesis currently exist. We are very encouraged by these results
and are looking forward to continuing clinical development in this under-addressed therapeutic area."
"We are very pleased with the results from the TZP-102 phase 2 trial showing sustained improvement
across a broad range of symptoms," said Vipin K. Garg, PhD, President and CEO of Tranzyme Pharma. "We look forward to initiating
the twelve week Phase 2b clinical trial for TZP-102 in the second half of 2011."
Tranzyme Pharma and Norgine B.V., have initiated dosing of ulimorelin in the first of two, Phase 3
pivotal studies – ULISES (ULImorelin Safety
and Efficacy Study). Ulimorelin
is Tranzyme’s intravenous promotility agent in development for the management of postoperative ileus (POI) in hospital
and acute care settings. POI is the temporary cessation of normal bowel motility after surgery preventing transit of intestinal
contents and tolerance of oral intake. Approximately 300 bowel surgery patients will be enrolled at sites across the US and
Europe in each of the two studies, ULISES 007 and ULISES 008. The objective is to evaluate the efficacy and safety of two,
once-daily, dosage regimens of ulimorelin (160 and 480µg/kg) in accelerating gastrointestinal (GI) recovery in patients undergoing
partial bowel resection. The primary endpoint of the study is the time to GI recovery defined as the time to the latest of
first bowel movement and first intake of solid food.
“Currently there are limited options for restoring GI function shortly after surgery, which
is a critical component for post-surgical recovery” said Vipin K. Garg, PhD, President and CEO of Tranzyme. “We
are committed to finding new and safe therapeutics for critical, unmet medical needs, and the commencement of this Phase 3
program is a vital step towards achieving that goal.”
There are an estimated 360,000 bowel resection surgeries performed annually in the United States.
In many cases POI results in an extended length of stay in the hospital, having a negative impact on the patient experience
and placing a considerable economic burden on hospitals and healthcare providers worldwide.
About Ulimorelin
Ulimorelin is an intravenous ghrelin agonist currently in clinical development for the management
of POI in acute care settings. Ulimorelin was discovered using Tranzyme’s proprietary drug discovery technology, and
is being co-funded by, and co-developed with specialty pharmaceutical firm Norgine B.V. based in the Netherlands. Norgine,
in turn, holds the commercial rights for ulimorelin in Europe, Oceania, Middle East, and North and South Africa.
About Norgine
Norgine is an independent, successful European specialty pharmaceutical company that has been established
for over 100 years and has a presence in all major European markets. In 2009, Norgine’s net product sales were €253
million, the 23rd year of double-digit growth at constant exchange rates. The company employs over 1,200 people.
Norgine’s focus is the development and marketing of pharmaceutical products that address significant
unmet clinical needs in areas such as gastroenterology, hepatology and supportive care. The company currently markets a range
of products in various markets in its key therapeutic areas e.g., MOVICOL® for the treatment of constipation and fecal impaction,
MOVIPREP® a bowel cleansing preparation, KLEAN-PREP® for bowel preparation prior to colonoscopy, XIFAXAN® for the treatment
of travelers’ diarrhea and ORAMORPH® for the treatment of moderate to severe pain associated with cancer.
Norgine is active in research and development and currently has products in various stages of clinical
development. Norgine manufactures most of its own products in Hengoed, Wales and Dreux in France.
August 25, 2010-Tranzyme Pharma
to Present Ulimorelin Data Showing Reduction in Daily Vomiting in Patients with Diabetic Gastroparesis
Professor of Medicine, Director, Clinical Research,
Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present ulimorelin
Phase 2 data at this year’s Joint International NGM Meeting on Saturday, August 28, 2010. The conference is being held
at the Westin Copley Place in Boston, MA. Professor Wo is scheduled to speak at 11:00am during Oral Session 3.
The presentation entitled, “Ulimorelin
(ghrelin agonist) effects on daily vomiting due to diabetic gastroparesis” will summarize the effects of ulimorelin
in subjects with daily, moderate to severe vomiting.
Gastroparesis, in severe cases, can be responsible
for frequent hospitalizations and emergency room admissions due to recurrent nausea and vomiting, which may be associated
with dehydration, malnutrition and weight loss due to inadequate caloric food intake. Currently, there are no safe and effective
treatments for gastroparesis. Earlier prescription medications used to treat this condition were either withdrawn from the
market or must carry a “black box” warning due to serious side effects.
In Tranzyme’s Phase 2 study of diabetic
patients with advanced gastroparesis, ulimorelin, given intravenously once daily for four days, demonstrated clinically and
statistically significant improvements in multiple gastroparesis-related symptoms, including vomiting and nausea.
Patients
who had moderate to severe daily vomiting during the 4 day run-in period (just prior to the study start), reported a marked
reduction in the number of days with vomiting during the subsequent 4-day treatment period.
June 29, 2010-Tranzyme Pharma Announces Positive
Results from Phase 2 Study of Oral TZP-102 (Ghrelin Agonist) in Patients with Diabetic Gastroparesis
Statistically Significant Results at Multiple
Dose Levels with Sustained Effect Throughout the 28-day Treatment Period
Tranzyme Pharma announced positive top-line results
today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis,
a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically
meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested
were effective, safe and well tolerated.
TZP-102 resulted in clinically meaningful improvement
in the severity of symptoms within one week of treatment initiation. At the end of the once-daily 28-day treatment period,
statistically significant improvements in symptom scores for Nausea, Early Satiety, Excessive Fullness, Postprandial Fullness
and total GCSI (Gastroparesis Cardinal Symptom Index), were observed, with p-values of 0.029, 0.001, 0.002, 0.020 and 0.015,
respectively. The average severity of symptoms during the 28-day treatment (mean of Days 8, 15 & 28) demonstrated similar
statistically significant improvements. TZP-102 also improved Upper & Lower Abdominal Pain/Discomfort (p=0.025 and p=0.016).
At the end of treatment, over 50% of patients on TZP-102 had normalized gastric emptying (vs. 20% on placebo).
“These positive TZP-102 data are exciting
for those of us treating patients with this critical disorder. Patients would truly benefit from a safe and effective oral
pharmacologic therapy for gastroparesis," commented Dr. Richard McCallum, Professor, Founding Chairman, Department of Internal
Medicine, Texas Tech University Health Sciences Center at El Paso, and a TZP-102 study investigator. “This represents
a medical area with significant unmet need and no recent evidence of any pharmacological advances. I certainly look forward
to further exploring the potential of TZP-102 in this and other gastrointestinal motility disorders.”
Dr. Gordana Kosutic, Vice President, Clinical and
Regulatory Affairs for Tranzyme said, “We are very pleased with these remarkable results and are now preparing to initiate
a 12-week efficacy and safety study in patients with gastroparesis."
Study Design
Ninety-two (92) patients with Type 1 or Type 2
diabetes mellitus and a confirmed diagnosis of gastroparesis, documented by the presence of both chronic symptoms and delayed
gastric emptying (GE), were enrolled in a Phase 2, double-blind, placebo-controlled parallel group study in the US and EU
designed to evaluate the safety and efficacy of TZP-102. Patients were randomly assigned to receive one of three daily doses
of TZP-102 (10, 20 & 40 mg administered as a single oral dose) or placebo, for a treatment period of 28 days. TZP-102’s
effects on symptom severity were evaluated by a validated patient-reported outcome (PRO) instrument, the Patient Assessment
of Gastrointestinal Symptoms scale (PAGI-SYM), and the Gastroparesis Cardinal Symptom Index (GCSI) after 8, 15, and 28 days
of treatment. The effects on GE were assessed by 13C-octanoic acid breath tests.
About TZP-102
TZP-102 is an oral ghrelin agonist with potent
prokinetic properties currently in clinical development for the treatment of chronic gastrointestinal dysmotility disorders
such as gastroparesis, functional dyspepsia, and refractory GERD. The safety and pharmacokinetic profiles of TZP-102 have
been extensively characterized in healthy subjects and patients across multiple dose levels, and the effectiveness of the
compound is well-established. TZP-102 was discovered by Tranzyme using its proprietary macrocyclic chemistry technology, MATCH™,
and targets the ghrelin receptor, which is found throughout the gastrointestinal (GI) tract. Currently, TZP-102 is the most
advanced oral medication in development for gastroparesis and other motility disorders affecting the GI tract. In recognition
of the critical unmet need, the FDA granted TZP-102 a Fast Track designation for the treatment of gastroparesis in diabetic
patients.
June 16, 2010 – Tranzyme Pharma, a clinical-stage biopharmaceutical company,
and Norgine B.V., a European specialty pharmaceutical company, announced today that they have entered
into a licensing agreement that provides Norgine with the exclusive rights to develop and commercialize
Tranzyme’s novel ghrelin agonist, ulimorelin (TZP-101), in Europe, Australia, New Zealand,
the Middle East, South Africa and North Africa. Ulimorelin is entering Phase 3 development for the
treatment of gastrointestinal dysmotility conditions in acute care settings.
Under the agreement, Norgine will make an upfront payment of $8 million and will
also make an equity investment in Tranzyme. Further, Tranzyme is eligible to receive up to approximately $150 million if certain
development, regulatory and commercial milestones are achieved. Tranzyme will also receive escalating double-digit royalties
on net sales in the licensed territories. The companies will jointly fund further development of ulimorelin
and anticipate initiating pivotal Phase 3 studies in the second half of 2010.
“Norgine’s focus on pharmaceutical products that address unmet medical
needs, and their development and commercial experience and expertise in European markets, make them an ideal strategic and
co-development partner for Tranzyme,” said Vipin K. Garg, PhD, President and CEO of Tranzyme. “This partnership
allows us to monetize part of the value of ulimorelin, while still retaining the significant upside
of North American and Asian markets”.
Peter Stein, Chairman and CEO of Norgine said, “There is a critical need
for a new, safe and effective prokinetic drug for use in acute care settings, as there are no satisfactory treatments on the
market.We have been very impressed with the work that Tranzyme have done to take ulimorelin
through Phase 2 development and we are excited to be working with them on this innovative therapy, which could bring relief
to millions of patients.”
About Ulimorelin
Ulimorelin is an intravenous
ghrelin agonist with potent prokinetic properties currently in clinical development for the treatment of gastrointestinal
dysmotility disorders in acute care settings. Ulimorelin has been comprehensively
studied in the management of severe gastroparesis and postoperative ileus (POI), and has the potential to treat other serious
conditions requiring administration of intravenous prokinetic agents. The safety and pharmacokinetic profiles of ulimorelin
have been extensively characterized in healthy subjects and patients across multiple dose levels, and the GI prokinetic properties
of the compound are well-established. Ulimorelin was discovered using Tranzyme’s proprietary
drug discovery technology.
About Norgine
Norgine is an independent,
successful European specialty pharmaceutical company that has been established for over 100 years and has a presence in all
major European markets. In 2009, Norgine’s net product sales were €253 million, the
23rd year of double-digit growth at constant exchange rates. The company employs over 1,200 people.
Norgine’s focus is the
development and marketing of pharmaceutical products that address significant unmet clinical needs in areas such as gastroenterology,
hepatology and pain management. The company currently markets a range of products in various markets
in its key therapeutic areas e.g., MOVICOL® for the treatment of constipation and fecal impaction, MOVIPREP® a new generation
of bowel cleansing preparation, KLEAN-PREP® for bowel preparation prior to colonoscopy, XIFAXAN® for the treatment of travelers’
diarrhea and ORAMORPH® for the treatment of moderate to severe pain associated with cancer.
Norgine is active in research
and development and currently has products in various stages of clinical development. Norgine manufactures
most of its own products in Hengoed, Wales and Dreux in France.
March 12, 2010-Tranzyme Pharma’s Clinical Results on Ulimorelin
(TZP-101) Selected for Oral Presentation at the Distinguished Abstract Plenary Session of Digestive Disease Week 2010
Tranzyme
Pharma announced today that data from the Phase 2 clinical trial of ulimorelin (TZP-101) for the treatment of severe gastroparesis
have been selected for an oral presentation at Digestive Disease Week (DDW) 2010 being held May 1-5, 2010 in New Orleans,
LA.
Ulimorelin has previously shown the ability to enhance gastric emptying in patients with severe diabetic gastroparesis.
The present analysis focused on the ability of this drug to relieve nausea and vomiting, which are the most serious and potentially
life-threatening complications of this disorder. Consistent with its effects on gastric emptying, ulimorelin significantly
reduced nausea and vomiting and improved overall symptomatology. These results further support ulimorelin’s future role
in the effective management of this debilitating condition.
“We are very pleased that the study results have been selected for presentation at this esteemed forum,”
said Gordana Kosutic, M.D., Vice President, Clinical and Regulatory Affairs for Tranzyme. “There are limited therapeutic
options to treat this serious medical condition and the clinical community is eagerly awaiting a new safe and effective prokinetic
therapy.”
The presentation will be given by Richard McCallum, M.D., Professor and Founding Chairman of the Department of Internal Medicine, Texas Tech University Health Sciences
Center at El Paso, and a Clinical Advisory Board member of Tranzyme, at the Neurogastroenterology and Motility Distinguished Abstract Plenary Session on Monday, May 3rd at 4:15pm EDT
in Rooms 283-285 of the Ernest N. Morial Convention Center.
About Ulimorelin
Ulimorelin is an intravenous ghrelin agonist with potent prokinetic properties in clinical development for the treatment
of gastrointestinal dysmotility conditions in acute care settings. Ulimorelin has been comprehensively studied in the management
of two indications, severe gastroparesis and postoperative ileus (POI), and has the potential to treat other conditions requiring
administration of intravenous prokinetic agents in critical care settings. The safety and pharmacokinetic profiles of ulimorelin
have been extensively characterized in healthy subjects and patients across multiple dose levels, and the GI prokinetic properties
of the compound have been well established.
January 27, 2010-Tranzyme Pharma Announces Approval of Generic Name “Ulimorelin” for TZP-101,
its First-in-Class Drug Candidate for the Treatment of Gastrointestinal Dysmotility
RESEARCH TRIANGLE PARK, N.C. (January 27, 2010) – Tranzyme Pharma today announced that the United States Adopted Name Council (USAN) has
approved the generic name “ulimorelin” for Tranzyme’s novel, late-stage, prokinetic agent TZP-101. Ulimorelin,
if approved, is expected to be a first-in-class drug for the treatment of gastrointestinal (GI) dysmotility indications in
acute care (hospital-based) settings. Ulimorelin is a small molecule, intravenously-administered drug that targets the ghrelin
receptor; ghrelin is responsible for energy homeostasis, appetite regulation and gastro-intestinal motility. The safety and
pharmacokinetic profiles of ulimorelin have been extensively characterized in healthy subjects and patients across multiple
dose levels, and the GI prokinetic properties of the compound have been well established in humans.
To date, ulimorelin has been successfully studied in two international Phase
2 trials, one for the management of postoperative ileus (POI) and a second for the treatment of acute gastroparesis, and has
the potential to treat other conditions where a safe and effective GI prokinetic therapy is desired in acute care settings.
July 27, 2009-Tranzyme Pharma Receives FDA Fast Track Status for Its Oral GI Prokinetic Drug Candidate TZP-102
Tranzyme Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation for the Company’s oral gastrointestinal (GI) prokinetic drug candidate TZP-102, for the treatment
of gastroparesis in diabetic patients. According to the FDA, gastroparesis is a serious complication of diabetes mellitus
that affects approximately 30-60% of diabetic patients.
Fast track designation is designed to
facilitate development and expedite review of a drugcandidate that treats a
serious or life-threatening condition and addresses an unmet medical need. In their approval letter, the FDA noted there are
limited treatment options for diabetic gastroparesis and agents currently available have serious side effects. TZP-102 qualifies
as a potential treatment for this extremely serious condition.
“We are extremely pleased that TZP-102 has received the FDA’s designation as a Fast Track
product,” commented Gordana Kosutic, MD, Tranzyme’s Vice President of Clinical and Regulatory Affairs. “We
routinely hear from patients suffering from gastroparesis who are excited about the progress of our clinical programs and
hopeful that a safe and effective therapy is forthcoming. Being granted Fast Track status is another milestone in helping
to meet that need.”
Tranzyme is currently enrolling patients
in a multi-national Phase 2, randomized, double-blind, placebo-controlled study of TZP-102. The outcomes will
evaluate the safety and efficacy of TZP-102 in accelerating gastric emptying and improving symptoms of gastroparesis in diabetic
patients.
About Gastroparesis
Gastroparesis is an impairment or paralysis of upper gastrointestinal tract function
characterized by delayed gastric emptying in the absence of mechanical obstruction. It is a significant complication of diabetes
mellitus and symptoms include nausea, vomiting, loss of appetite and early satiety, and may affect nutrient delivery to the
small intestine with resultant fluctuations in blood glucose levels, loss of weight, and malnutrition. Gastroparesis may also
result from abdominal surgery or be idiopathic in nature. The only FDA approved drug for gastroparesis is metoclopramide,
for which the FDA recently ordered a “black box” warning due to the risk of often irreversible tardive dyskinesia
(involuntary movement disorder). In spite of these severe side effects, more than 2 million patients use the drug in the U.S.
alone. Cisapride, formerly used widely in the treatment of gastroparesis, has been removed from the market owing to safety
issues.
June 23, 2009-Tranzyme
Pharma CEO Vipin Garg WINS Ernst & Young Entrepreneur Of The Year® 2009 Award
RTP, NC (June 23, 2009) – Tranzyme
Pharma, a clinical stage biotechnology company, today announced that its President and CEO, Vipin K. Garg, PhD, received the
Ernst & Young Entrepreneur Of The Year® 2009 Award in the health
sciences category for the Carolinas Region. According to Ernst & Young LLP, the award recognizes outstanding entrepreneurs
who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses
and communities. Dr. Garg was selected by an independent panel of judges and the award was presented at a celebration banquet
at the Westin Charlotte on June 18, 2009.
The
program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.
“I am grateful for Ernst & Young’s continued dedication and commitment to supporting
and recognizing entrepreneurs worldwide and I want to thank all of the sponsors of this year’s magnificent event”,
said Garg. “I am honored to receive this most prestigious recognition and graciously accept it on behalf of my Tranzyme
colleagues and our supportive investors and board members, as it is indeed a reflection of our collective efforts.”
As a regional award winner, Dr. Garg is eligible for consideration for the Ernst & Young LLP Entrepreneur
Of The Year national program. Award winners in several national categories, as well as the overall national Ernst & Young
Entrepreneur Of The Year award winner, will be announced at the annual awards gala in Palm Springs, California on November
14, 2009. The awards are the culminating event of the Ernst & Young Strategic Growth Forum, the nation’s most prestigious
gathering of high-growth, market-leading companies.
Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year awards are pleased
to have the Ewing Marion Kauffman Foundation and SAP America as national sponsors.
In
the Carolinas, sponsors included King & Spalding, Bowne and Business Leader Media.
About Ernst & Young’s Entrepreneur Of The Year® Awards Program
Ernst & Young’s Entrepreneur Of The Year® Award is
the world’s most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages
entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their
vision, leadership and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur
Of The Year® award celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them
through regional, national and global awards programs in more than 135 cities in 50 countries.
May 5, 2009-Tranzyme Pharma Initiates Dosing in a Phase 2 Study of its Oral Ghrelin
Agonist TZP-102 in Patients with Gastroparesis
RESEARCH TRIANGLE PARK, N.C. (May 5, 2009) – Tranzyme Pharma today announced that it has initiated dosing in a Phase
2 study of TZP-102, its potent and selective second generation oral ghrelin agonist, in diabetic patients with gastroparesis.
Gastroparesis is an inability of the stomach to empty food efficiently, and comprises a prevalent and serious complication
of diabetes mellitus. The characteristics of the compound allow for chronic administration in an out-patient setting.
This Phase 2, randomized, double-blind, placebo-controlled study to be conducted at multiple sites in the US and Europe, will evaluate
the safety and efficacy of three 28-day, once-daily, dosage regimens of TZP-102 (10, 20 & 40 mg) in accelerating gastric
emptying and improving symptoms of gastroparesis among 80 patients with diabetic gastroparesis.
“Initiating this study of TZP-102, our second novel, internally discovered compound, is another
important milestone for Tranzyme. This follows on the recent completion of two successful Phase 2 trials of our lead product
TZP-101 (ghrelin agonist for IV administration) for the treatment of gastroparesis in acute settings and postoperative ileus
(POI),” commented Vipin K. Garg, PhD, President and CEO of Tranzyme. “We remain committed to finding new and safe
therapeutics for critical, unmet medical needs.”
About TZP-102
TZP-102 is a novel, orally administered prokinetic agent that acts by a mechanism distinct from previously
developed products for gastrointestinal (GI) motility disorders. TZP-102 is a second generation agonist of the ghrelin receptor
(which is distributed in both the upper and lower GI tract). TZP-102 has the potential to treat gastroparesis and other
chronic GI and motility disorders, including GERD, functional dyspepsia, opioid bowel dysfunction and irritable bowel syndrome
with constipation. TZP-102 originated from Tranzyme’s proprietary MATCH™ drug discovery technology.
Tranzyme Pharma’s Successful Phase 2 Postoperative
Ileus Trial Results to be Presented at the American Society of Colon and Rectal Surgeons 2009 Annual Meeting
RESEARCH TRIANGLE PARK, N.C. (May 4, 2009) – Tranzyme Pharma today
announced that Anthony J. Senagore, MD, MBA, MS, FACS, Vice President, Research & Education of Spectrum Health and Professor
of Surgery, Michigan State University/CHM, will present results from the successful study of ghrelin agonist TZP-101 for the
management of postoperative ileus (POI) at the upcoming 2009 Annual Meeting of the American Society of Colon and Rectal Surgeons
(ASCRS) being held from May 2-6, 2009. Dr. Senagore’s presentation will take place on Wednesday, May 6, 2009 at 4:50
p.m. EST in the Atlantic Ballroom of the Westin Diplomat Hotel in Hollywood, FL.
POI is a transient impairment of gastrointestinal (GI) function following abdominal
or other surgery and is often protracted and exacerbated by multiple factors including the use of opioids for pain management.
Symptoms include abdominal distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet.
Delays in resuming a normal diet may lead to poor wound healing and increased risk of infection through a cascade of events.
POI is associated with an increased length of hospital stay and is the most common cause of delayed hospital discharge after
abdominal surgery. The prolonged hospitalization raises the possibility for serious pulmonary complications. In the United
States alone, 2.4 million patients undergo open abdominal surgery each year and are at high risk for POI (Source: Premier
Database). No unrestricted treatments for POI have been approved by the US Food and Drug Administration to date.
Tranzyme is planning a Phase 3 trial with TZP-101 for POI with the primary efficacy
endpoint of “GI2” - the time to GI function recovery as defined by the later of first bowel movement (BM) and
first solid food intake. The Phase 2 study (which enrolled ~250 patients undergoing partial large bowel resection) demonstrated
TZP-101’s ability to reduce the time to GI2 by 23.3 hours over placebo (PBO), and that difference is clinically and
statistically significant (p<0.05). Another clinically important endpoint, the proportion of patients who had early recovery
of GI function (within 72 hours) indicated a marked increase on TZP-101 (65% of patients) over placebo (25% of patients).
The observed difference was evidently significant (p=0.004). The most typical adverse events for the post-surgical population,
nausea and vomiting, were noticeably decreased in the TZP-101 group as compared to placebo. In the placebo group, nausea
and vomiting were reported for 27% and 16% patients, respectively. In contrast, for the two most effective study doses, fewer
than 5% of TZP-101 patients experienced nausea or vomiting, consistent with the strong GI prokinetic activity of TZP-101 and
the early GI recovery.
April 22, 2009-Tranzyme Pharma Announces Positive Phase 2 Results
with TZP-101 for Improvement of Symptoms in Patients with Gastroparesis RESEARCH TRIANGLE PARK, N.C. (April 22, 2009)
– Tranzyme that its first-in-class, potent and selective ghrelin agonist, TZP 101, demonstrated effectiveness
in the treatment of gastroparesis, an inability of the stomach to empty food efficiently, especially in patients with diabetes
mellitus (DM). Clinical trial results indicated that TZP-101 was safe and highly effective in improving multiple symptoms
associated with gastroparesis.
A total of 76 patients with either type 1 or type 2 DM and a confirmed diagnosis of
gastroparesis (by presence of both chronic symptoms and objective demonstration of delayed gastric emptying) were enrolled
in a US and EU, double-blind, placebo-controlled Phase 2 trial designed to evaluate the safety and efficacy of TZP-101. Patients
were voluntarily admitted to the hospital and adaptively randomized to receive a daily 30-min IV infusion of one of six doses
of TZP-101 (20-600ìg/kg) or placebo for 4 consecutive days. Overall, 57 subjects received TZP-101 and 19 received placebo.
Patient safety was monitored by vital signs, ECGs, physical exams, clinical chemistry and adverse events.
During treatment
and at a 30-day follow-up visit, efficacy was evaluated by symptom improvement as assessed by both the patients and the investigators.
The Gastroparesis Cardinal Symptom Index (GCSI), a questionnaire for assessing the severity of symptoms associated with
gastroparesis, was administered to each subject prior to dosing, on each of the treatment days and at the follow-up visit.
Additionally, meal-related Gastroparesis Symptom Assessment (GSA) and Clinician Rated Symptom Assessment (CRSA) scores
were collected for the study.
Summary Results: 80ìg/kg was determined to be the TZP-101 dose which achieved maximum
clinical benefit. Upon completion of the 4-day dosing period, improvement in symptoms in TZP-101-treated subjects was statistically significant
(or trending toward significance) over placebo-treated subjects as determined by one or more of the evaluation tools (GCSI,
GSA, CRSA) for the following symptoms: vomiting (p=0.006), loss of appetite (p=0.034), postprandial fullness (p=0.007), early
satiety (p=0.087), abdominal distension (p=0.053) and bloating (p=0.0822). Statistical significance was also observed by the
CRSA Overall Symptom scores (p=0.046). The 30-day follow-up evaluation demonstrated a sustained benefit in symptom improvement
in the TZP-101 group. This effect reached statistical significance (p=0.023) for vomiting, a particularly debilitating
complication of gastroparesis. In addition, proportionally fewer subjects (3%) in the TZP-101 group required hospitalization
for gastroparesis during the 30-day follow-up period versus the placebo group (10%). TZP-101 was safe and well-tolerated
at all doses tested.
"We are encouraged to see that TZP-101, given intravenously for only 4 days, induced an acute
and sustained reduction of symptoms offering a potential new therapy for patients with gastroparesis and other GI motility
disorders in acute settings," said Gordana Kosutic, MD, Vice President, Clinical and Regulatory Affairs for Tranzyme. "These
results are consistent with the potent prokinetic properties of TZP-101 and complement our previously reported successful
Phase 2 study with TZP-101 for the management of postoperative ileus (POI)."
"We recognize the severity of symptoms
caused by gastroparesis and their impact on quality of life, and are anxious to bring relief to the millions of patients suffering
from this condition. We now plan to initiate a Phase 3 program to further evaluate the efficacy and safety of TZP-101 in
this patient population," stated Vipin K. Garg, PhD, President and CEO of Tranzyme.
March 11, 2009-Tranzyme Pharma Announces Issuance
of Three New Patents Further Strengthening Company’s Advanced Ghrelin Agonist Programs
RESEARCH TRIANGLE PARK, N.C. (March 11, 2009) - Tranzyme
Pharma, a late stage biopharmaceutical company engaged in the discovery and development of first-in-class small molecule therapeutics,
announced today that the U.S. Patent and Trademark Office (USPTO) has issued three patents further enhancing Tranzyme’s
intellectual property portfolio for its current and future drug candidates. They are:
§ US 7,476,653: Macrocyclic modulators of the ghrelin
receptor
§ US 7,491,695: Methods of using macrocyclic
modulators of the ghrelin receptor
§ US 7,452,862: Conformationally-controlled
biologically active macrocyclic small molecules as motilin antagonists or ghrelin agonists
Combined, these patents, with terms until at least 2024, provide
strong and broad protection for the chemical structural class comprising Tranzyme’s lead pharmaceutical development
programs. Further, they provide Tranzyme with specific protection for the therapeutic uses of its ghrelin agonists in the
treatment of gastrointestinal (GI) motility disorders, and for the composition-of-matter of the Company’s most advanced
drug candidate, TZP‑101. TZP-101 is an intravenous ghrelin agonist ready to enter Phase 3 studies for the management
of postoperative ileus (POI).
In addition, these patents expand coverage around the
Company’s proven drug discovery technology, Macrocyclic Template Chemistry (MATCH™), from which Tranzyme’s
entire pipeline of novel therapeutics is derived.
“The validation by the USPTO of the novelty of TZP-101
and its uses is another significant milestone in bringing new therapeutic options to market for the treatment of serious and
costly unmet medical needs,” said Vipin K. Garg, PhD, Tranzyme’s President and CEO. “We expect this drug
will become the first-line option for the treatment of POI, a condition for which nearly 1 million open surgical patients
are at risk in the U.S. each year, as well as for other indications in acute settings where an intravenous prokinetic drug
is required.”
"These patent issuances reflect our strategy to construct
a broad and robust IP portfolio to protect each of our pharmaceutical development programs as well as the underlying technology,"
stated Mark L. Peterson, PhD, Vice President, Intellectual Property & Operations, for Tranzyme Pharma.
About Postoperative Ileus
Postoperative ileus is a transient impairment of GI motility
following abdominal or other surgery with symptoms which can include abdominal distention, pain, nausea and vomiting, and
inability to pass stools and tolerate a solid diet. Delays in resuming a normal diet may lead to poor healing and patients
are at greater risk for pulmonary complications since POI may result in reduced patient mobility. POI is associated with an
increased length of hospital stay and is the most common cause of delayed hospital discharge after abdominal surgery. In the
United States alone, nearly 1 million people undergo high risk open surgery each year (Source: Premier Database). No unrestricted
treatments for POI have been approved by the U.S. Food and Drug Administration to date.
About TZP-101
TZP-101, Tranzyme’s intravenous ghrelin agonist,
is the first product from the Company’s internal drug discovery efforts. TZP-101 is being evaluated clinically for the
treatment of POI and gastroparesis in acute care settings and has the potential to address other indications requiring administration
of intravenous prokinetic agents. In addition to the recent successful POI Phase 2b trial, an additional Phase 2b trial for
the management of gastroparesis is nearing completion. The safety and pharmacokinetic profiles of TZP-101 have been extensively
characterized in healthy subjects across multiple dose levels, and the GI prokinetic properties of the compound have been
well established in humans and various animal models, with or without concomitant opioids. In addition to TZP-101, Tranzyme
is developing an oral ghrelin agonist, TZP-102, for the out-patient treatment of gastroparesis and other chronic GI motility
disorders, including GERD and functional dyspepsia. TZP-102 will enter Phase 2 trials later this year.
March 3, 2009-'EVOKE PHARMA DEVELOPING ITS DIABETIC
GASTROPARESIS DRUG IN STEALTH MODE'
San Diego-based Evoke Pharma has managed to maintain a low
profile since early 2007, when the specialized drug development company got started with the help of some prominent names
in the local biotech industry.
Cam Garner, who is listed on Evoke’s web site as a co-founder and chairman, has been on the ground floor of Cadence
Pharmaceuticals and at least six other San Diego life sciences startups. Ken Widder, who has founded seven biomedical companies,
including NovaCardia and Santarus, also is identified as an Evoke board member.
So when a brief surfaced recently about Evoke getting some new venture funding, I called CFO Matt D’Onofrio
to clarify the terms and to learn a little more about Evoke and how it got started. D’Onofrio took my call, but he declined
to discuss the deal, saying Evoke prefers to remain in stealth mode at this time. He told me all that Evoke is saying is what’s
available on the company’s web site.
As limited as it is, the information is pretty interesting.
A lone Evoke Pharma press release, which was dated June 15, indicates the company was headed at that time
for a late-stage clinical trial of a new drug candidate for treating a particular gastrointestinal disorder known as diabetic
gastroparesis. Evoke elsewhere describes gastroparesis generally as a common problem affecting some 8 million Americans in
which the stomach is unable to contract normally, and therefore cannot crush food or push it into the small intestine properly.
The symptoms include vomiting, bloating and pain.
Evoke says diabetes is a major cause of gastroparesis, accounting
for almost one-third of all cases, although the specific mechanism is unknown. After announcing the successful completion
of an early stage trial in its June press release, Evoke said it was planning to discuss its results and a late-stage clinical
trial strategy with the FDA in October, with an eye toward starting final-stage trials in 2009.
That’s about the extent of the information available
from Evoke’s web site, and the company issued no follow-up announcement in the fall. So perhaps that’s when CEO
Dave Gonyer and the board decided it was time to slip below the radar. In fact, they had never really called attention
to the company in the first place.
Nevertheless, some additional information is available from
an amended disclosure form concerning Evoke’s venture investors, which the company filed with state officials in December.
The paperwork shows Evoke has raised a total of almost $12.3 million in equity investments since the company was founded two
years ago, although it doesn’t reveal how many tranches it has taken. The investors include Domain Associates, a venture
capital firm in Princeton, NJ, that is among San Diego’s most-active life sciences investors, Latterell Venture Partners
of San Francisco and individual investors.
Even if Evoke won’t discuss how they’re using
the venture funding, it’s nice to know that some local biotechs are still getting funded.
Phase 2 Development For The Treatment Of Gastroparesis
RESEARCH TRIANGLE PARK, N.C. (January 6, 2009) Tranzyme
Pharma, a clinical stage biopharmaceutical company engaged in the discovery and development of first-in-class small molecule
therapeutics, announced today that Vipin K. Garg, Ph.D., President and CEO, will present at the upcoming 27th Annual JP Morgan
Healthcare Conference being held from January 12-15, 2009. Tranzyme’s presentation will take place on Monday, January
12, 2009 at 8:30 a.m. PST at the Westin St. Francis Hotel in San Francisco, CA.
Dr. Garg will provide a corporate and product overview
as well as a summary of positive clinical results for the company’s first-in-class, highly potent and selective ghrelin
agonists, TZP-101 and TZP-102. During Q1 2009, TZP-101 is scheduled to enter a Phase 3 trial for the management of postoperative
ileus (POI), and TZP-102 will enter into Phase 2 development for the treatment of gastroparesis.
About Tranzyme Pharma
Tranzyme Pharma is engaged in the discovery and development
of breakthrough small molecule therapeutics for the treatment of both acute care (hospital-based) and chronic indications
with significant unmet medical needs. In addition to TZP-101 and TZP-102, the company is developing a ghrelin antagonist,
TZP-301, for the treatment of obesity and metabolic syndrome, and a motilin antagonist, TZP-201 for the treatment of various
forms of moderate-to-severe diarrhea.
Tranzyme has developed a pipeline of novel drugs through
its proprietary MATCH™ drug discovery technology which accelerates the progression of compounds from discovery to commercial
track by generating small molecule drug candidates that display the favorable characteristics exhibited by large biomolecules,
such as tight receptor binding for high potency and exquisite target selectivity, while maintaining the benefits typically
associated with small molecule drugs including oral bioavailability, cost of synthesis, and ease of formulation.
Tranzyme Pharma Receives Notices
of Allowance from USPTO on Two Patents Protecting Company’s Lead Pharmaceutical Development Programs
RESEARCH TRIANGLE PARK, N.C. (July 22,
2008) - Tranzyme Pharma, a leading biopharmaceutical company developing novel mechanism-based therapeutics for the treatment
of gastrointestinal (GI) and metabolic disorders, announced today that the Company has received Notices of Allowance from
the U.S. Patent and Trademark Office (USPTO) for two patent applications entitled “Macrocyclic Modulators of the Ghrelin
Receptor” and “Spatially-Defined Macrocyclic Compounds Useful for Drug Discovery”.
Together, the
patents expected to be issued based on these notices of allowance, with anticipated terms until 2025 and 2024, respectively,
would provide strong and broad protection for the chemical structural class comprising Tranzyme’s primary pharmaceutical
development programs, including the composition-of-matter of TZP-101, the Company’s leading drug candidate. TZP-101
is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb trials for the treatment of postoperative
ileus (POI) and gastroparesis. In addition, these patents will expand coverage around the Company’s proven drug discovery
technology, Macrocyclic Template Chemistry (MATCH™),
from which Tranzyme has developed its pipeline of first-in-class therapeutics.
“These Notices of Allowance represent
a significant milestone for the Company as they will lead to the first patents related directly to our pharmaceutical development
programs and affirm the uniqueness and patentability of our macrocyclic structures,” stated Mark L. Peterson, PhD, Vice
President, Intellectual Property & Operations, for Tranzyme Pharma.
About Postoperative Ileus Postoperative
ileus is a transient impairment of GI motility following abdominal or other surgery with symptoms which can include abdominal
distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet. Delays in resuming a normal
diet may lead to poor healing through a cascade of events, and patients are at greater risk for pulmonary complications since
POI may result in reduced patient mobility. POI is associated with an increased length of hospital stay and is the most common
cause of delayed hospital discharge after abdominal surgery. In the United States alone, it is estimated that 22 million patients
undergo surgical procedures requiring pain management and of these patients, 2.4 million undergo high risk open surgery each
year (Source: Premier Database). No unrestricted treatments for POI have been approved by the US Food and Drug Administration
to date.
Tranzyme Pharma’s Ghrelin Agonist
TZP-102 Demonstrates Safety and High Oral Bioavailability in the Successful Completion of a Phase I Trial
RESEARCH TRIANGLE PARK, N.C. and SHERBROOKE, Québec (June 17, 2008) - Tranzyme
Pharma announced today the successful completion of a Phase I, placebo-controlled, single ascending dose study of its orally
administered ghrelin agonist, TZP-102. TZP-102 is the second drug candidate from Tranzyme’s internal R&D efforts
to reach clinical development. It is a potent prokinetic agent initially being developed for the treatment of mild-to-moderate
gastroparesis.
The Phase I study showed that TZP-102 has excellent oral bioavailability in man and is safe and well-tolerated
at all five doses (10-80 mg) tested. Most importantly, all doses achieved plasma concentrations of TZP-102 above those associated
with significantly increased rates of gastric emptying in a validated animal model. A multi-dose Phase I study of TZP-102
in healthy volunteers has been initiated and the company expects to begin its first proof-of-concept trial of TZP-102 in the
fourth quarter of 2008.
TZP-102 is a product that complements Tranzyme’s pipeline of first-in-class therapeutics
for the treatment of both acute (hospital based) and chronic gastrointestinal and metabolic disorders with significant unmet
medical needs. Whereas TZP-102 is expected to be developed for the management of chronic gastrointestinal disorders, Tranzyme’s
lead drug candidate, TZP-101, is an injectable ghrelin agonist being evaluated in two concurrent Phase IIb trials for the
treatment of acute indications, severe gastroparesis and post-operative ileus (POI).
“Tranzyme’s novel
approach to drug discovery allows our compounds to retain the favorable characteristics of small molecules, such as the high
oral bioavailability demonstrated by TZP-102, while exhibiting the characteristics of large biomolecules, such as tight receptor
binding for high potency and exquisite target selectivity,” stated Helmut Thomas, Ph.D., DABT, Sr. Vice President, Research
and Preclinical Development of Tranzyme Pharma.
June 17, 2008-Tranzyme Pharma’s Ghrelin
Agonist TZP-102 Demonstrates Safety and High Oral Bioavailability in the Successful Completion of a Phase I Trial
RESEARCH TRIANGLE PARK, N.C. (June 17, 2008) - Tranzyme Pharma announced today the successful completion of a Phase I, placebo-controlled,
single ascending dose study of its orally-administered ghrelin agonist, TZP-102. TZP-102 is the second drug candidate from
Tranzyme’s internal R&D efforts to reach clinical development. It is a potent prokinetic agent initially being developed
for the treatment of mild-to-moderate gastroparesis.
The Phase I study showed that TZP-102 has excellent oral bioavailability in man and is safe and well-tolerated
at all five doses (10-80 mg) tested. Most importantly, all doses achieved plasma concentrations of TZP-102 above those
associated with significantly increased rates of gastric emptying in a validated animal model. A multi-dose Phase I study
of TZP-102 in healthy volunteers has been initiated and the company expects to begin its first proof-of-concept trial of TZP-102
in the fourth quarter of 2008.
TZP-102 is a product that complements Tranzyme’s pipeline of first-in-class therapeutics for
the treatment of both acute (hospital based) and chronic gastrointestinal and metabolic disorders with significant unmet medical
needs. Whereas TZP-102 is expected to be developed for the management of chronic gastrointestinal disorders, Tranzyme’s
lead drug candidate, TZP-101, is an injectable ghrelin agonist being evaluated in two concurrent Phase IIb trials for the
treatment of acute indications, severe gastroparesis and post-operative ileus (POI).
“Tranzyme’s novel approach to drug discovery allows our compounds to retain the favorable
characteristics of small molecules, such as the high oral bioavailability demonstrated by TZP-102, while exhibiting the characteristics
of large biomolecules, such as tight receptor binding for high potency and exquisite target selectivity,” stated Helmut
Thomas, Ph.D., DABT, Sr. Vice President, Research and Preclinical Development of Tranzyme Pharma.
About TZP-102
TZP-102 is a first-in-class, orally administered GI prokinetic agent that acts by a mechanism distinct from
previously developed products for gastrointestinal (GI) motility disorders. TZP-102 is an agonist of ghrelin receptors found
in both the upper and lower GI tract. The drug is expected to enter Phase II development in late 2008
June 5, 2008-Tranzyme Pharma to Present “Ghrelin Agonist
(TZP-101) Effects on Patients with Severe Symptomatic Diabetic Gastroparesis” at ADA 2008
RESEARCH TRIANGLE PARK, N.C. (June 5, 2008) - Tranzyme Pharma, a leading biopharmaceutical company that discovers and develops small molecule drugs
for the treatment of gastrointestinal and metabolic diseases, announced today that Dr. Niels Ejskjaer, MD, PhD of Aarhus University
Hospital, Denmark, will present Phase IIa trial results of Tranzyme’s first-in-class ghrelin agonist TZP-101 at the
American Diabetes Association, 68th Annual Meeting to be held in
San Francisco, CA, June 6-10, 2008.
Using scintigraphy and a standardized radiolabeled meal, this double blind, randomized, two-way crossover
study assessed the effects of TZP-101 on gastric emptying in 10 patients with long standing type 1 or type 2 diabetes and
severe symptomatic gastroparesis. Data show that TZP-101 induced a statistically significant reduction in half-emptying time
(p=0.043) and latency time (p=0.037) of the solid meal. It is of special significance that gastric emptying of the solid meal
was normalized in 30% of patients after a single TZP-101 infusion. Half-emptying and latency times for liquids were reduced
as well. Further, TZP-101 infusion decreased a cumulative meal-related symptom score in 5 of 8 patients with an overall improvement
of 24%. Postprandial fullness, the most frequent and severe symptom observed in the study, was reduced by 37%.
“No efficient pharmacotherapy exists for diabetic gastroparesis, thus threatening the health
of diabetic patients,” stated Dr. Ejskjaer, the study’s principal investigator. “This TZP-101 proof-of-concept
study data show a clinically relevant improvement of gastric emptying and suggest that TZP-101 is a promising agent for the
management of gastroparesis,” he added.
The abstract number 298-OR will be presented
in Room 130 of the Moscone Center on Monday, June 9, 2008 at 6:15pm.
Tranzyme Pharma Initiates Dosing in Humans with Second Drug Candidate TZP-102
RESEARCH TRIANGLE PARK, N.C. (March 3, 2008)
- Tranzyme Pharma today announced that it has commenced dosing in a Phase I study of TZP-102, the Company’s second generation,
orally-administered ghrelin agonist. TZP-102 is a potent prokinetic agent that Tranzyme is initially developing for the treatment
of mild-to-moderate gastroparesis, with other chronic gastrointestinal (GI) motility disorders to follow.
The Phase I trial is a two-part double-blind, placebo-controlled evaluation of single ascending doses, followed by a
crossover multi-dose evaluation in healthy human volunteers. In addition to safety, other objectives of the study include
the assessment of pharmacokinetic properties and pharmacodynamic effects of ghrelin receptor agonist activity.
Tranzyme develops small molecule drugs from its proprietary macrocyclic chemistry platform, MATCHTM,
for the treatment of GI and metabolic diseases. TZP-102 operates through the same mechanism of action as the lead drug, TZP-101,
an intravenous ghrelin agonist currently undergoing Phase IIb trials for the treatment of post-operative ileus (POI) and severe
gastroparesis. “We are very excited
to begin characterizing the safety and tolerability of TZP-102,” said Gordana Kosutic, M.D., Tranzyme’s Vice President,
Regulatory and Clinical Affairs. “We anticipate progressing TZP-102 into Phase II investigation by the end of this year.”
“Gastrointestinal disorders are expected to affect over 250 million people worldwide by 2012,” stated Vipin
K. Garg, Ph.D., President & CEO of Tranzyme Pharma. “Having two GI promotility drug candidates in the clinic is
a great milestone for Tranzyme, and is extremely encouraging for patients and caregivers alike since many competing promotility
agents have safety issues that have resulted in their restriction or removal from the market.
Tranzyme Pharma Receives IND Clearance
for Its Oral Ghrelin Agonist,TZP-102, for the Treatment of Gastroparesis Phase I Safety and Tolerability Trial to Begin
RESEARCH
TRIANGLE PARK, N.C. (January 29, 2008) - Tranzyme Pharma announced today that the US Food and Drug Administration (FDA) completed
its review of the Company's Investigational New Drug (IND) application for TZP-102, Tranzyme's second drug candidate to reach
clinical development.
Tranzyme is a clinical stage company developing small molecule drugs for the treatment of gastrointestinal
(GI) and metabolic diseases. TZP-102 operates on the same mechanism of action as the Company's lead product TZP-101, an intravenous
ghrelin agonist currently undergoing Phase IIb trials for the treatment of two distinct acute GI motility disorders: post-operative
ileus (POI) and severe gastroparesis. TZP-102 is a second generation prokinetic drug that Tranzyme intends to develop for
the treatment of mild-to-moderate gastroparesis and other chronic GI motility disorders. A Phase I safety and tolerability
trial of TZP-102 will begin immediately.
"Advancing TZP-102 into clinical development further strengthens our product
pipeline," commented Vipin K. Garg, Ph.D., President & CEO of Tranzyme Pharma. "Acceptance of this IND by the FDA represents
a significant milestone for Tranzyme as well as for the technology underlying the discovery and development of this product.
TZP-102 is the second clinical candidate to originate from our proprietary macrocyclic chemistry platform, MATCHTM,"
Dr. Garg added.
"We are genuinely excited by the progression of TZP-102 to the clinic as preclinical evidence suggests
this oral prokinetic agent has therapeutic potential for symptomatic relief and management of chronic gastroparesis," stated
Gordana Kosutic, M.D., Tranzyme's Vice President, Regulatory and Clinical Affairs.
About Gastroparesis
Gastroparesis
is a paralysis of upper gastrointestinal tract function characterized by delayed gastric emptying in the absence of mechanical
obstruction. Symptoms of gastroparesis include post-prandial fullness, early satiety, nausea, vomiting, and upper abdominal
pain. Disease severity ranges from mild to moderate to severe. Gastroparesis is a major complication of diabetes; it may also
result from abdominal surgery and can be idiopathic in nature.
*NO
EFFICACIOUS THERAPY IS AVAILABLE FOR GASTROPARESIS. CURRENT TREATMENTS ARE ONLY MODERATELY EFFECTIVE AND MANY ARE ASSOCIATED WITH
ADVERSE NEUROLOGICAL SIDE EFFECTS.
It is estimated that approximately 5 million patients suffer from Gastroparesis
in the United States.
MOVETIS NV -Belgian Biopharmaceutical Company
Two Movetis Compounds Successfully Progressing Through
Phase II Clinical Trials In Gastrointestinal (GI) Disorders-Gastroparesis-Results from clinical trial in 2009
Turnhout, 08 January 2008, Movetis NV, a
European-based specialist pharmaceutical company, announced today that M0002, an orally-active selective V2 vasopressin antagonist
for the treatment of ascites has successfully completed enrollment in a Phase IIa clinical trial, and that M0003, an innovative
gastrokinetic compound for the treatment of paediatric reflux and gastroparesis has now begun a Phase IIa clinical trial in
patients with gastroparesis.
M0003 is a powerful, and specific, high affinity
5-HT4 agonist that stimulates upper GI motility and accelerates gastric emptying at low dose. It is currently being studied
for the treatment of gastroparesis, a disorder in which the stomach takes too long to empty its contents, as well as paediatric
reflux, or involuntary regurgitation of gastric contents into the oesophagus. Results from the Phase IIa clinical trial of
M0003 in gastroparesis are expected in 2009. 'We are encouraged to see that our compounds are successfully progressing
through research on time and within budgets. Obviously we are honoured that the IWT institute feels our programme merits such
a grant and we are committed to work with them to progress innovation and create jobs in our region." commented Dirk Reyn,
CEO of Movetis "Through these grants and the support of our distinguished investors, we can pursue our path to discover, develop
and ultimately commercialise innovative treatments targeting selected GI conditions where patients do not get adequate relief
from older drugs with less favourable benefit/risk profiles" .
*MOVETIS NV - founded 2007 - is an
independent Belgian biopharmaceutical company which specializes in developing compounds for gastrointestinal (GI) disorders.
The current portfolio has been licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., US, two
Johnson & Johnson (JNJ) companies.
"Tranzyme Pharma"
Tranzyme Pharma to Present at
the 26th Annual JPMorgan Healthcare Conference
RESEARCH TRIANGLE PARK, N.C. & SHERBROOKE, Quebec--(BUSINESS
WIRE)--Tranzyme Pharma, a leading biopharmaceutical company developing small molecule drugs for the treatment of gastrointestinal
(GI) and metabolic diseases, announced today that Vipin K. Garg, Ph.D., President and CEO, will present at the upcoming 26th Annual
JPMorgan Healthcare Conference being held from January 7-10, 2008. Tranzyme’s presentation will take place on Monday,
January 7, 2008 at 3:30 p.m. PST at the Westin St. Francis Hotel in San Francisco, CA.
Dr. Garg will provide a corporate
overview and an update on the two ongoing Phase IIb clinical trials of Tranzyme’s lead product, TZP-101, an intravenous
ghrelin agonist being investigated for the treatment of severe gastroparesis and post-operative ileus. In July 2007, the
FDA granted TZP-101 fast-track designation for severe gastroparesis.
*FDA PUTS NEW GASTROPARESIS MEDICATION
ON FAST TRACK-TREATMENT AVAILABLE ON THE MARKET-2010
Durham biotech Tranzyme Pharma has received fast-track status from the U.S. Food and Drug Administration
for its drug TZP-101 - a move that could have the treatment to market within three years.
That's six months to a year quicker than Tranzyme
could have hoped for without fast-track designation. No wonder, then, that the company's looking to the future - and even
to an initial public offering by 2009.
"We're a smart group of people," says Eric Nelson,
the company's vice president of business development. "We're planning ahead."
The FDA designation, meant to speed the release to
market of drugs that address unmet medical needs, will give Tranzyme expedited review of TZP-101. The drug is a treatment
for severe gastroparesis, a condition in which damaged stomach nerves lead to delays in digestion. Severe gastroparesis can
lead to nausea and vomiting, and it can also interfere with the treatment of diabetes.
Eric Nelson, Tranzyme vice president of business
development, said fast-track status puts the company on pace to bring the drug to market in 2010, with full phase II trials
set to start in the third quarter of 2007.
The company estimates that the worldwide market for
the treatment of severe gastroparesis is $500 million annually.
Tranzyme, which has 10 employees in the Triangle
and 40 overall, also is developing TZP-101 for the treatment of post-operative ileus, a condition in which patients' bowels
stop working or work too slowly after surgery. The worldwide market for that condition is $1 billion, Nelson said.
Also $1 billion: the market for TZP-102, an oral
form of TZP-101 for less severe gastroparesis. That drug is in preclinical trials and could enter human studies later this
year.
Those are not small numbers. Nor is the $32 million
the company raised in its last round of financing in May 2005 from lead investors H.I.G. Ventures, Quaker BioVeutures and Thomas, McNerney & Partners.
But for the company to make the money, Nelson said,
it first has to raise the money for its trials.
In the short term, that means following one of three
paths: partnering with a major pharmaceutical company, taking in another round of financing or doing both. Of those, Nelson
says, "Frankly, we're evaluating all those options."
And in the longer term? Perhaps an initial public
offering, maybe next year or in 2009. The company has already attracted interest from multiple investment banks, though Nelson
declined to give names.
"Things are looking very good," Nelson said.
Tranzyme
Pharma Closes New $20 Million Financing
RESEARCH TRIANGLE PARK, N.C. and SHERBROOKE, Québec (November 1, 2007) - Tranzyme
Pharma, a leading biopharmaceutical company developing small molecule drugs for the treatment of gastrointestinal (GI) and
metabolic diseases, announced today that it has completed a new round of private financing, raising a total of $20 million.
The financing was led by existing investors H.I.G. Ventures, Thomas, McNerney & Partners, Quaker BioVentures, and BDC
Venture Capital.
Tranzyme intends to use this funding to further advance clinical development of its breakthrough GI
drugs. Tranzyme’s lead products are first-in-class drugs directed at modulating ghrelin and motilin receptors in the
GI tract. The Company recently initiated two Phase IIb clinical trials to test the efficacy and safety of its first product,
TZP-101, an intravenous ghrelin receptor agonist being investigated for the treatment of severe gastroparesis and post-operative
ileus. In July 2007, the FDA granted TZP-101 fast-track designation for severe gastroparesis.
Tranzyme’s pipeline
also includes TZP-102, an oral ghrelin agonist for the treatment of mild-to-moderate (chronic) gastroparesis and other functional
GI disorders. In addition, the Company is developing a motilin antagonist, TZP-201, for moderate to severe diarrhea, and a
ghrelin antagonist, TZP-301 for obesity and metabolic syndrome.
“Tranzyme has made tremendous progress since
the last round of financing in 2005 and all of its investors are extremely excited by the blockbuster potential of the Company’s
mechanism-based drug candidates,” stated David J. Drutz, M.D., Chairman of Tranzyme Pharma’s board, and General
Partner with Pacific Rim Ventures, Co., Ltd.
“This round of financing reflects the continued support and confidence
we are so fortunate to have from our investors,” stated Vipin K. Garg, Ph.D., President and Chief Executive Officer
of Tranzyme. This capital will allow us to bring our first-in-class GI motility drug, TZP-101, into Phase III clinical studies
for multiple indications.”
Tranzyme Pharma Initiates Dosing
of Patients in a Multi-NationalPhase IIb Clinical Trial for the Treatment of Severe Gastroparesis
RESEARCH TRIANGLE
PARK, N.C. and SHERBROOKE, Québec (October 30, 2007) - Tranzyme Pharma today announced the initiation of a Phase IIb clinical
trial of its potent intravenous ghrelin agonist, TZP-101, for the management of severe gastroparesis. TZP-101 is a first-in- class
prokinetic agent under development for the treatment of selected GI motility disorders. In July 2007, Tranzyme initiated enrollment
in a Phase IIb clinical trial for post-operative ileus.
The severe gastroparesis Phase IIb trial, now underway in the
US, Denmark and Sweden, is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to assess the efficacy
and safety of TZP-101 in subjects suffering from severe diabetic gastroparesis. The study has an adaptive randomization design,
and could potentially enroll up to 100 subjects. The primary objective of this study is to assess the impact of TZP-101 on
symptoms as defined by a change from baseline in a validated gastroparesis symptom scoring assessment.
In July 2007,
TZP-101 received fast track designation from the FDA for the treatment of severe gastroparesis based on Tranzyme's positive
Phase IIa clinical data. In the Phase IIa study, TZP-101 not only demonstrated a statistically significant increase in gastric
emptying (measured by scintigraphy) but also improved symptoms in 10 patients with long-standing diabetes, poor glycemic control,
and significant gastropathy. Postprandial fullness, the most frequent and severe symptom observed with these patients,
was reduced 37% by TZP-101. This state-of-the-art simultaneous controlled investigation, carried out during euglycemic hyperinsulinemic
clamp (in highly selective homogenous patients), demonstrated for the first time that TZP-101 both accelerates gastric
emptying of solid food and improves symptoms characteristic of gastroparesis. These observations clearly suggest that TZP-101
is a potential break-through drug for the management of severe gastroparesis.
Severe gastroparesis is a cause of significant
patient morbidity. Frequent hospitalizations, emergency room and physician office visits may result from the difficulties
in managing this disorder and its diabetes-associated metabolic complications. The impact on people's lives, and the economic
and resource burdens that gastroparesis places on the healthcare system, stresses the importance of developing an effective
and safe treatment for this indication. Most current drug treatments are only moderately effective at best, and may cause
neurological side effects.
"As of today, no efficient treatment for diabetic gastroparesis exists. The ability of
TZP-101 to address both gastric emptying and symptoms of gastroparesis will potentially make this drug a unique first-in-class
treatment for this extremely difficult medical condition," said Dr. Niels Ejskjaer, principal investigator from the Aarhus
University Hospital, Denmark.
About TZP-101 TZP-101 is a potent, small molecule ghrelin receptor agonist that Tranzyme
is developing for the treatment of severe gastroparesis and post-operative ileus. The safety and pharmacokinetic profile of
TZP- 101 has been characterized in 50 healthy subjects across multiple dose levels. The prokinetic properties of the compound
have been well established in various animal models of postoperative ileus and more recently in diabetic patients with severe
gastroparesis. In addition to TZP-101, Tranzyme is developing an oral ghrelin agonist, TZP-102, for the treatment of mild-to-moderate
gastroparesis and other chronic GI motility disorders.
About Severe Gastroparesis Gastroparesis is a paralysis of
upper gastrointestinal tract function characterized by delayed gastric emptying in the absence of a mechanical cause of obstruction.
Disease severity ranges from mild to moderate to severe. Symptoms include post-prandial fullness, bloating, nausea, vomiting,
and upper abdominal pain. Severe gastroparesis, or gastroparesis with gastric failure, is characterized by refractory symptoms
that are not controlled despite medical therapy. Patients suffering from severe gastroparesis are often unable to maintain
nutrition, or medication via oral delivery. Because of their unremitting symptoms, they may be dependent on gastric suctioning
and enteral/parenteral nutrition. Gastroparesis is a major complication of diabetes. The World Health Organization estimates
that 180 million people have diabetes. Approximately 5% of Type 1 and 25% of Type 2 diabetic patients, or 13 million worldwide,
are believed to suffer from gastroparesis. In addition, there may be a nearly equal number of patients who suffer from gastroparesis
due to other causes.
FDA DRUG REVIEW STEPS
1-Preclinical (animal) testing. Pre-IND
2-An investigational new drug application (IND) outlines what the sponsor of a
new drug proposes for human testing in clinical trials.
3-Phase 1 studies (typically involve 20 to 80 people).
4-Phase 2 studies (typically involve a few dozen to about 300 people).
5-Phase 3 studies (typically involve several hundred to about 3,000 people).
6-The pre-NDA period, just before a new drug application (NDA) is submitted. A
common time for the FDA and drug sponsors to meet.
7-Submission of an NDA is the formal step asking the FDA to consider a drug for
marketing approval.
8-After an NDA is received, the FDA has 60 days to decide whether to file it so
it can be reviewed.
9-If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's
research on the drug's safety and effectiveness.
10-The FDA reviews information that goes on a drug's professional labeling (information
on how to use the drug).
11-The FDA inspects the facilities where the drug will be manufactured as part
of the approval process.
12-FDA reviewers will approve the application or find it either "approvable"
or "not approvable."
