RESEARCH TRIANGLE PARK, N.C. and SHERBROOKE, Québec (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, MATCH™," 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.
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.