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Bowel drug being studied by Tranzyme and Norgine fails to make the grade
by Jeffrey Bouley  |  Email the author


RESEARCH TRIANGLE PARK, N.C. and AMSTERDAM, The Netherlands—Tranzyme Pharma and Norgine B.V. on March 12 announced top-line results of the primary analysis of ULISES 007, the first of two pivotal Phase III clinical trials evaluating the gastrointestinal (GI) drug ulimorelin, reporting that the trial failed to meet its primary and secondary efficacy endpoints.
"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 Dr. Vipin K. Garg, president and CEO of, Tranzyme Pharma. "We are now focusing on our oral drug TZP-102 which is currently in a Phase IIb trial for the treatment of diabetic gastroparesis. In this trial, we are looking for improvement in upper GI symptoms over a twelve-week treatment period."  
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, which 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.
Key summary data include:
  • Median time to GI2 was approximately 80 hours in all arms.
  • Median duration of therapy was approximately 3.5 days in all arms.
  • 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 approximately 330 patients to once-daily IV administration of 160 micrograms/kg of ulimorelin, 480 micrograms/kg of ulimorelin, or placebo.
Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics for the treatment of upper GI motility disorders. While approximately 40 percent of people in the United States. are affected by these persistent and recurring conditions that disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options, the company notes.
Tranzyme is developing TZP-102, an oral ghrelin agonist with reportedly potent prokinetic properties for treating the symptoms associated with chronic GI motility disorders. This product candidate targets a significant underserved market. Enrollment in a multinational, phase IIb trial is ongoing; top-line data is expected by year-end 2012.
Norgine is an independent, European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2011, Norgine's net product sales were 250 million Euros, and the company employs more than 1,200 people. Norgine's focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology and supportive care.

Code: E03121201



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