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Tranzyme Pharma Announces Successful Completion of Phase I Clinical Trial of Its Novel Ghrelin Agonist, TZP-101

Posted on: Wednesday, 10 May 2006, 09:07 CDT

Tranzyme Pharma announced today that it has successfully completed a Phase I clinical trial of its first drug candidate, TZP-101, a new chemical entity originating from the Company's proprietary small molecule macrocyclic chemistry technology. TZP-101 is a selective ghrelin receptor agonist with potent gastroprokinetic properties that represents the first in its class to enter into a clinical trial. Tranzyme Pharma is developing TZP-101 as a mechanism-based therapy for post-operative ileus (POI) and other gastrointestinal (GI) motility disorders. The Phase I study demonstrated that TZP-101 is safe and well tolerated in healthy subjects and that the safety and pharmacokinetic profile of the compound support further clinical development.

"We are extremely excited to reach this important milestone with TZP-101, our first product to enter clinical development," said Vipin K. Garg, Ph.D., President & CEO of Tranzyme Pharma. "With TZP-101 leading the way, Tranzyme is building a rich internal pipeline of novel drug candidates to address important medical needs including GI motility disorders, obesity and diabetes. Our rapid progress in drug discovery and development is clear testimony to the robustness of our proprietary chemistry technology and our ability to design agonists and antagonists with selective and potent activity on pharmaceutically relevant targets."

The first-in-man trial just completed was an ascending dose, placebo-controlled study in which healthy volunteers (total 48 subjects) were randomly assigned to receive one of six TZP-101 dose levels or placebo as a 30-minute intravenous infusion. "These data demonstrate that the tolerability, safety and a highly attractive pharmacokinetic profile of TZP-101 support continuing clinical development," said Gordana Kosutic, M.D., Vice President of Clinical and Regulatory Affairs for Tranzyme Pharma. "The Company will now proceed to evaluate the safety and pharmacodynamic activity of the drug in a multiple-dose study in healthy subjects and in a single-dose study in Type 1 diabetic patients experiencing delayed gastric emptying."

In extensive preclinical studies, Tranzyme's ghrelin agonists have been shown to stimulate gastric emptying in naive rats, and to reverse delayed GI transit in rats caused by abdominal surgery (a model of POI), high caloric intake (a model of gastroparesis), and treatment with morphine (a model of opioid-induced GI dysfunction). Tranzyme is developing its ghrelin agonists both as an intravenous therapy (TZP-101) for acute, hospital-based applications and as an orally administered product (TZP-102) for chronic GI disorders.

Tranzyme Pharma is a clinical-stage company developing small molecule therapeutics for the treatment of gastrointestinal (GI) and metabolic diseases. The Company's candidate drugs originate from its own discovery pipeline of proprietary compounds with high potency and selectivity for validated and druggable targets. Tranzyme is developing first-in-class, mechanism-based therapeutics for post-operative ileus (POI), gastroparesis, obesity, diabetes and functional GI disorders. For more information, please visit: www.tranzyme.com.

Source: Business Wire

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