Tranzyme Pharma to Present “Ghrelin Agonist (TZP-101) Effects on Patients with Severe Symptomatic Diabetic Gastroparesis” at ADA 2008



RESEARCH TRIANGLE PARK, N.C. and SHERBROOKE, Québec (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.

About TZP-101
TZP-101 is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb trials for the treatment of severe gastroparesis and post-operative ileus (POI). The safety and pharmacokinetic profile of TZP-101 has been extensively characterized in healthy subjects across multiple dose levels, and the prokinetic properties of the compound have been well established in various animal models. 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 Gastroparesis
Gastroparesis is an impairment or 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, abdominal pain, nausea, vomiting, and weight loss. Disease severity ranges from mild to severe. Gastroparesis is a major complication of diabetes leading to metabolic imbalance when liquid and food intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal surgery or be idiopathic in nature. Current medications for the treatment of gastroparesis 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