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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
Data Presented at 2011 Digestive Disease Week (DDW)
CHICAGO, IL - 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."
Gastroparesis is a debilitating, chronic condition characterized by slow or delayed gastric emptying and gastric retention that can be caused by any disease that induces neuromuscular dysfunction of the GI tract, notably diabetes. Up to 4% of the population in the United States experiences symptomatic manifestations of gastroparesis. There are currently no safe and effective therapies on the market for treating this disorder.Earlier medications prescribed for this indication were withdrawn from the market or must carry a black box warning due to serious side effects.
TZP-102 targets the ghrelin receptor, a novel mechanism of action, with a highly potent and direct role in the stimulation of GI motility. TZP-102 is an orally-administered promotility agent in clinical development for the treatment of gastroparesis in diabetic patients. Currently, there are no safe and effective treatments for gastroparesis. In recognition of this critical unmet need, the FDA has granted TZP-102 a Fast Track designation. TZP-102 was discovered by Tranzyme using its proprietary macrocyclic chemistry technology, MATCH™.
About Tranzyme Pharma
Tranzyme Pharma (www.tranzyme.com) is a clinical‑stage biopharmaceutical company focused on discovering, developing and commercializing novel, first-in-class small molecule therapeutics for the treatment of acute (hospital‑based) and chronic gastrointestinal (GI) motility disorders. All of Tranzyme's product candidates have been discovered using its proprietary drug discovery (chemistry) technology, MATCH™, which enables the construction of synthetic libraries of drug-like, macrocyclic compounds in a predictable and efficient manner.
The Tranzyme, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=9438
About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract.The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
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