FONT-SIZE Plus   Neg

Tranzyme Pharma Says That First Phase 3 Pivotal Trial Of Ulimorelin Failed

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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Apple confirmed that it has bought face animation software firm Faceshift, although it was tight lipped about how it intends to use the new addition. The move is speculated as a bid to expand into virtual reality. Environment ministry of South Korea Thursday ordered Volkswagen Korea to recall 125,522 diesel vehicles on determining actual emissions of nitrogen oxides. The ministry has asked the German automobile maker to pay a fine of 14.1 billion Won or $12.31 million. The company has to submit a recall plan by January 6, 2016. The U.S. Food and Drug Administration has alerted health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several...
comments powered by Disqus
Follow RTT