Tranzyme, Inc. (TZYM) announced today that its drug candidate, TZP-102, did not meet its primary efficacy endpoint. Tranzyme’s Phase IIb study was for two doses of TZP-102 taken once daily against a placebo. Even all patients saw a reduction in gastroparesis symptoms after 12 weeks of treatment, the difference between TZP-102 and placebo was minimum and not statistically significant.
Vipin K. Garg, PhD, President and Chief Executive Officer of Tranzyme, commented:
We are understandably disappointed with the results of this trial; however, our second Phase 2b trial known as DIGEST is ongoing. In DIGEST we are evaluating a 10 mg dose of TZP-102 administered three times daily before meals, rather than once daily as in the trial just completed. We anticipate announcing top line results for DIGEST in the first half of 2013
Gastroparesis is a progressive disorder that causes paralysis of a stomach which leads to nausea, vomiting and digestion problems. There are no currently approved drugs to treat gastroparesis and TZYM’s outgoing Phase 2b DIGEST study may be a solution for the treatment that makes TZYM shares attractive at price below a dollar level.
We believe that TZYM shares will bounce back up in a near-term.
Cash-reach company – market capitalization 50% below TZYM’s cash/share.
DIGEST study is outgoing – preliminary data should be at the beginning of 2013.
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Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 40 percent of people in the U.S. are affected by these persistent and recurring conditions which disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options. Tranzyme is developing TZP-102, an oral ghrelin agonist for treating the symptoms associated with chronic upper GI motility disorders.