Tranzyme and Norgine's ulimorelin fails to meet endpoints

USA-based Tranzyme Pharma (Nasdaq: TZYN) and independent Dutch drugmaker Norgine have announced disappointing top-line results of the primary analysis of ULISES 008, the second of two Phase III pivotal trials evaluating ulimorelin in postoperative ileus.

Consistent with the ULISES 007 data released earlier this year (The Pharma Letter March 12), ULISES 008 did not meet the primary and secondary endpoints as there was no statistical difference between the ulimorelin and placebo groups. The two trials were identical in design and population.

ULISES 008 was a double-blind, multinational, placebo-controlled study to evaluate ulimorelin in accelerating GI recovery in subjects who had undergone partial bowel resection. The study was designed to randomize approximately 330 patients to once-daily IV administration of either 160 or 480 micrograms/kg of study drug, or placebo. The primary endpoint was 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.