Tranzyme Announces DIGEST Trial Stopped After Insufficient Efficacy from Phase 2b Results

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.