Bowel drug being studied by Tranzyme and Norgine fails to make the grade

No statistical difference between drug and placebo seen in terms of primary endpoints in first of two Phase III trials

Jeffrey Bouley
RESEARCH TRIANGLE PARK, N.C. and AMSTERDAM, TheNetherlands—Tranzyme Pharma and Norgine B.V. on March 12 announced top-line results of the primary analysisof 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 anddisappointing. 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, weare stopping all other NDA activities for ulimorelin," said Dr. Vipin K. Garg, president and CEO of, Tranzyme Pharma. "We are nowfocusing on our oral drug TZP-102 which is currently in a Phase IIb trial forthe treatment of diabetic gastroparesis. In this trial, we are looking forimprovement in upper GI symptoms over a twelve-week treatment period."
 
 
The results of ULISES 007 show that ulimorelin, atboth 160 and 480 micrograms/kg doses, was not statistically different fromplacebo for the primary endpoint, which was the time to recovery of GI function asdefined by the time from the end of surgery to GI2. GI2 is defined as the laterof first bowel movement and tolerance of solid food.
 
Key summary data include:
  • Median time to GI2 was approximately 80 hours inall arms.
  • Median duration of therapy was approximately 3.5days in all arms.
  • Both doses of ulimorelin were well tolerated.
     
ULISES (ULImorelin Safety and Efficacy Study) 007is one of two Phase 3 pivotal, double-blind, multinational, placebo-controlledstudies to evaluate the efficacy and safety of IV ulimorelin administeredpostoperatively to accelerate GI recovery in subjects who have undergonepartial bowel resection. The study was designed to randomize approximately 330patients to once-daily IV administration of 160 micrograms/kg of ulimorelin,480 micrograms/kg of ulimorelin, or placebo.
 
Tranzyme Pharma is a late-stage biopharmaceuticalcompany focused on discovering, developing and commercializing novel,mechanism-based therapeutics for the treatment of upper GImotility disorders. While approximately 40 percent of people in the United States. areaffected by these persistent and recurring conditions that disrupt the normalmovement of food throughout the GI tract, currently there are a limited numberof safe and effective treatment options, the company notes.
 
Tranzyme is developing TZP-102, anoral ghrelin agonist with reportedly potent prokinetic properties for treating thesymptoms associated with chronic GI motility disorders. This product candidatetargets 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, Europeanspecialty pharmaceutical company that has been established for over 100 yearsand has a presence in all major European markets. In 2011, Norgine's netproduct sales were 250 million Euros, and the company employs more than 1,200 people. Norgine'sfocus is the development and marketing of pharmaceutical products that addresssignificant unmet clinical needs in therapeutic areas such as gastroenterology,hepatology and supportive care.


Jeffrey Bouley

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