Late-stage biopharmaceutical company Tranzyme Pharma (TZYM), on Monday, along with specialty pharmaceutical company Norgine B.V., announced top-line results of the primary analysis of ULISES 007, the first of two Phase 3 pivotal trials evaluating ulimorelin.
The company stated that the trial failed to meet its primary and secondary efficacy endpoints.
Tranzyme further stated that the results of ULISES 007 showed that ulimorelin, at both 160 and 480 micrograms/kg doses, was not statistically different from placebo for the primary endpoint.
"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.
by RTT Staff Writer
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