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Tranzyme earlier reported that TZP-101 demonstrated excellent tolerability and safety, as well as a desirable pharmacokinetic profile in healthy subjects in two Phase I clinical studies. The Company plans to initiate full Phase II development of TZP-101 for both POI and severe gastroparesis in 3Q 2007. In addition to the ongoing clinical testing of TZP-101 (an intravenous drug), Tranzyme is developing a new oral ghrelin agonist, TZP-102. Tranzyme expects to initiate Phase I clinical testing of TZP-102 in the first quarter of 2008 for the treatment of mild to moderate chronic gastroparesis.
"The Company is making great progress in the development of TZP-101," said Dr. Vipin Garg, President & CEO of Tranzyme Pharma. "Tranzyme's novel ghrelin agonists (TZP-101 and TZP-102) are promising breakthrough drugs with huge commercial potential. Most prokinetic agents under development and on the market act on predominantly central nervous system receptor targets that are also found in the GI tract. Many show potentially serious CNS side effects. Our small molecule ghrelin agonists target a receptor that is more directly involved with regulating gastrointestinal motility."
About Gastroparesis
Gastroparesis results from dysfunction of the nerves of the
stomach, leading to postprandial fullness, bloating, early satiety,
nausea and vomiting. The three most common etiologies of
gastroparesis are diabetes (an estimated 30% of gastroparesis
patients), unknown etiology (36%), and post-surgical causes (13%).
The prevalence rate of gastroparesis is especially high among
diabetic patients, as up to 50% of diabetics worldwide are reported
to suffer from gastroparesis
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