Press Release
For Immediate Release – 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 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 postprandial fullness, early satiety, abdominal pain, nausea, vomiting and weight loss. Gastroparesis is a significant 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 limited, are only moderately efficacious and have undesirable side effects (most notably, neurological). It is estimated that approximately 5 million patients in the US suffer from gastroparesis.
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.
About Tranzyme Pharma
Tranzyme Pharma is a late stage biopharmaceutical company engaged in the discovery and development of first-in-class small molecule therapeutics for the treatment of both acute care (hospital-based) and chronic indications with significant unmet medical needs. For more information on Tranzyme, please visit: http://www.tranzyme.com.