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Tranzyme Pharma Presents Positive Preclinical Data for Its Novel GI Therapeutics; Data Presented at Fifth International Symposium on Growth Hormone Secretagogues

Posted on: Monday, 1 November 2004, 09:00 CST

Tranzyme Pharma Inc., a leading biopharmaceutical company developing small molecule therapeutics for the treatment of gastrointestinal (GI) disorders, presented positive preclinical data for its lead ghrelin agonists at the Fifth International Symposium on Growth Hormone Secretagogues in Camogli, Italy. Tranzyme is developing small molecule ghrelin agonists as first-in-class treatments for post-operative ileus (POI) and diabetic gastroparesis--serious medical conditions in which motility of the GI tract is severely impaired.

The data demonstrate that Tranzyme's proprietary ghrelin agonists are potent and selective for the human ghrelin receptor. In a rat model, these compounds stimulated significant gastric emptying in a dose-dependent manner with 100-fold greater potency than metoclopramide, a marketed prokinetic compound currently prescribed to treat gastroparesis. In addition, Tranzyme Pharma's compounds exhibit a highly desirable pharmacokinetic profile and excellent oral bioavailability. The data presented at this meeting were developed by a Tranzyme Pharma team led by Graeme L. Fraser, Ph.D., Vice President, Pharmacology & Drug Discovery.

"We are very excited to have successfully advanced our programs into preclinical development," said Vipin K. Garg, Ph.D., President & CEO for Tranzyme Pharma. "We are on track to file an IND for POI by Q4 2005. We expect to initiate Phase I clinical trials for this indication by the end of 2005, followed shortly thereafter by Phase I trials for diabetic gastroparesis."

About POI and diabetic gastroparesis

POI is an impairment of GI motility that is an inevitable consequence of major abdominal and pelvic surgery (1.4 million cases per year in U.S.). There are no FDA-approved products for POI. Diabetic gastroparesis affects Type I and Type II diabetics with up to 10% of these patients requiring hospitalization for nausea, vomiting, abdominal pain and malnutrition. Existing medical and surgical approaches to this condition offer poor efficacy and/or severe side effects. Moreover, the two most popular products for the treatment of gastroparesis (cisapride and domperidone) have been removed from the U.S. market due to adverse side effects.

About the role of ghrelin in GI motility

Ghrelin is the most potent endogenous peptide known to stimulate gastric motility. Recent independent clinical studies have clearly demonstrated that infused ghrelin peptide potently stimulates gastric emptying in both human volunteers and diabetic gastroparesis patients. However, the ghrelin peptide has limited utility as a therapeutic product for GI indications due to its brief pharmacokinetic half-life and poor oral bioavailability.

Tranzyme Pharma is a leading biopharmaceutical company developing novel orally bio-available, small molecule therapeutics for the treatment of gastrointestinal (GI) diseases. The Company's candidate drugs originate from its own discovery pipeline of proprietary compounds with high affinity for validated and druggable targets in the GI tract. Tranzyme is developing mechanism-based therapeutics for post-operative ileus, diabetic gastroparesis, irritable bowel syndrome (diarrhea-type) and functional dyspepsia and is on track to enter the clinic with its first product by the end of 2005. Tranzyme is leveraging its technologies through internal programs and partnerships to drive the discovery and development of new therapeutics. For more information visit: www.tranzyme.com.

Source: Business Wire

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