ULISES 007 (ULImorelin Safety and Efficacy Study) is the first of two phase III pivotal, double-blind, multinational, placebo-controlled studies to evaluate the efficacy and safety of IV ulimorelin administered postoperatively to accelerate gastrointestinal (GI) recovery in subjects who have undergone partial bowel resection.
"These results are surprising and disappointing. While we are still planning to analyze the data from the second phase III 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 CEO, Tranzyme Pharma.
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. Median time to GI2 was approximately 80 hours in all arms and median duration of therapy was approximately 3.5 days in all arms. Both doses of ulimorelin were well tolerated.
Garg said Tranzyme is refocusing on its oral drug TZP-102, which is currently in a phase IIb trial for the treatment of diabetic gastroparesis. In this trial, researchers are looking for improvement in upper GI symptoms over a 12-week treatment period.