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news.Tranzyme Pharma has successfully completed a Phase I, placebo-controlled, single ascending dose study of its orally administered ghrelin agonist, TZP-102.
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The Phase I study showed that TZP-102 has excellent oral bioavailability in man and is safe and well-tolerated at all five doses (10-80 mg) tested. Most importantly, all doses achieved plasma concentrations of TZP-102 above those associated with significantly increased rates of gastric emptying in a validated animal model.
A multi-dose Phase I study of TZP-102 in healthy volunteers has been initiated and the company expects to begin its first proof-of-concept trial of TZP-102 in the fourth quarter of 2008.
TZP-102 is the second drug candidate from Tranzyme’s internal R&D efforts to reach clinical development. It is a potent prokinetic agent initially being developed for the treatment of mild-to-moderate gastroparesis.
Helmut Thomas, senior vice president, research and preclinical development at Tranzyme Pharma, said: “Tranzyme’s novel approach to drug discovery allows our compounds to retain the favorable characteristics of small molecules, such as the high oral bioavailability demonstrated by TZP-102, while exhibiting the characteristics of large biomolecules, such as tight receptor binding for high potency and exquisite target selectivity.”