UPDATE: Tranzyme Pharma Preliminary Analysis Indicates Study Did Not Meet Primary Endpoint

Tranzyme Pharma

and Norgine B.V. today announced top-line results of the primary analysis of ULISES 007, the first of two Phase 3 pivotal trials evaluating ulimorelin. The trial failed to meet its primary and secondary efficacy endpoints. "These results are surprising and disappointing. While we are still planning to analyze the data from the second phase 3 trial ULISES 008, which we expect by the end of the second quarter, we are stopping all other NDA activities for ulimorelin," said Vipin K. Garg, Ph.D., President and Chief Executive Officer, Tranzyme Pharma. "We are now focusing on our oral drug TZP-102 which is currently in a phase 2b trial for the treatment of diabetic gastroparesis. In this trial, we are looking for improvement in upper GI symptoms over a twelve-week treatment period." The results of ULISES 007 show that ulimorelin, at both 160 and 480 micrograms/kg doses, was not statistically different from placebo for the primary endpoint, the time to recovery of GI function as defined by the time from the end of surgery to GI2. GI2 is defined as the later of first bowel movement and tolerance of solid food. Key summary data include: