Tranzyme Inc. (NASDAQ:TZYM), a clinical-stage bio-pharmaceutical company, said the preliminary analysis of its ULISES 007 pivotal trial evaluating ulimorelin indicated study failed to meet its primary and secondary efficacy endpoints, sending its shares 70.59% lower in premarket trading.
Tranzyme and Norgine B.V. announced top-line results of the primary analysis of ULISES 007, the first of two Phase 3 pivotal trials evaluating ulimorelin, which failed to meet its primary and secondary efficacy endpoints.
While still planning to analyze the data from the second phase 3 trial ULISES 008, which the company expects by the end of the second quarter, Tranzyme is stopping all other NDA activities for ulimorelin.
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.
Key summary data include: median time to GI2 was approximately 80 hours in all arms; median duration of therapy was about 3.5 days in all arms; and both doses of ulimorelin were well tolerated.
ULISES (ULImorelin Safety and Efficacy Study) 007 is one of two Phase 3 pivotal, double-blind, multinational, placebo-controlled studies to evaluate the efficacy and safety of IV ulimorelin administered postoperatively to accelerate GI recovery in subjects who have undergone partial bowel resection.
The study was designed to randomize about 330 patients to once-daily IV administration of 160 micrograms/kg of ulimorelin, 480 micrograms/kg of ulimorelin, or placebo. Top-line results in the second pivotal trial, ULISES 008 (identical in design and population to ULISES 007), are expected to be announced by the end of the second quarter 2012.
Tranzyme Chief Executive Vipin Garg said the company is now focusing on oral drug TZP-102 which is currently in a phase 2b trial for the treatment of diabetic gastroparesis. In this trial, the company is looking for improvement in upper GI symptoms over a twelve-week treatment period.
TZYM closed Friday's regular trading down 0.59% at $5.10. The stock has been trading between $2.38 and $5.70 for the past 52 weeks.