Tranzyme Pharma (TZYM) and Norgine B.V. announced the results of the primary analysis of ULISES 008, the second of two Phase 3 pivotal trials evaluating ulimorelin in postoperative ileus. Tranzyme Pharma stated that consistent with the ULISES 007 data released in March 2012, 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 company stated that 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.
"These results confirm the findings of the earlier ULISES 007 study and support our earlier decision to stop all NDA activities for ulimorelin," said Franck Rousseau, Chief Medical Officer, Tranzyme Pharma.
"Tranzyme is now focusing its development efforts on TZP-102, an oral ghrelin agonist in Phase 2b for the treatment of diabetic gastroparesis. Diabetic gastroparesis is a chronic upper GI motility disorder and since the preponderance of ghrelin receptors are located in the upper GI tract, we believe TZP-102 is well suited for this indication. Top-line results from the Phase 2b trial are expected by the end of the year," said Franck Rousseau.
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