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1/16/2013 8:17:17 AM
Tranzyme Pharma is a late-stage biopharmaceutical company developing novel small molecule drugs to address chronic upper gastrointestinal and other disorders with high unmet medical need. History of Tranzyme: On November 15th 2012, Tranzyme Pharma (TZYM) announced top-line results of the preliminary analysis of the first of two Phase 2b trials assessing the safety and efficacy of its oral ghrelin agonist, TZP-102 in diabetic patients with gastroparesis. The results, which evaluated patients who were given a single daily dose of 10 mg of TZP-102, 20 mg of TZP-102 or placebo for 12 weeks indicate the trial did not meet its primary efficacy endpoint. Oh oh, investors lost a ton of money. Share price went from $3.97 to $0.95 that day. On the bright side, this was only the first of the two Phase 2b trials right? The second trial had a dosing of three times a day. Could this make a difference? On December 17th, Tranzyme Pharma today announced it is discontinuing and immediately ending patient enrollment in DIGEST, a Phase 2b trial in diabetic patients receiving TZP-102 for the management of symptoms of gastroparesis, due to insufficient efficacy. The decision followed a planned interim futility analysis, which examined patients' responsiveness to thrice daily oral dosing of 10mg of TZP-102 or placebo at the end of weeks 4 and 8 of a 12 week trial. The results are consistent with the findings of a prior Phase 2b trial in that there was a very large placebo effect and no treatment effect.
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