Ulimorelin (Tranzyme) fails in ULISES 007 trial for Post Operative Ileus

The intravenous ghrelin agonist, ulimorelin, from Tranzyme Pharma/Norgine failed to meet its primary efficacy endpoint of accelerating recovery of GI function versus placebo in the Phase III ULISES 007 trial of subjects who have undergone bowel resection surgery. In the ULISES 007 trial ulimorelin was given at either 160mcg or 480mcg and was not statistically different from the placebo group for the primary endpoint of time to recovery of GI function, which is defined as the time from the end of surgery to the later of the first bowel movement and tolerance of solid food.Tranzyme still plans to analyse the data from a second, identical Phase III trial, known as ULISES 008, which is expected by the end of second quarter 2012.Plans for filing at the FDA are postponed.