Tranzyme Pharma (TZYM) Thursday announced that 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 patient with gastroparesis did not meet its primary efficacy endpoint.
The clinical-stage bio pharmaceutical company stated that the primary efficacy endpoint of the trial was the change from baseline in the Gastroparesis Symptom Daily Diary, or GSDD composite score during the final two weeks of a 12-week treatment period.. The GSDD composite score reflects the mean severity of the four principal symptoms of gastroparesis: nausea, early satiety, bloating and upper abdominal pain.
"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," said Vipin K. Garg, PhD, President and Chief Executive Officer of Tranzyme.
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