Tranzyme Pharma & Norgine Announce Top-Line Data
Tranzyme Pharma and Norgine B.V. recently announced 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 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 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 S. Rousseau, MD, Chief Medical Officer, Tranzyme Pharma. “Tranzyme is now focusing its development efforts on TZP-102, an oral ghrelin agonist in Phase IIb for the treatment of diabetic gastroparesis. Diabetic gastroparesis is a chronic upper GI motility disorder and because 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 IIb trial are expected by the end of the year.”
Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 40% of people in the
Tranzyme is developing TZP-102, an oral ghrelin agonist for treating the symptoms associated with chronic upper GI motility disorders. This product candidate targets a significant underserved market. Enrollment in a multinational, Phase IIb trial is ongoing; top-line data are expected by year-end 2012. By leveraging its proprietary drug discovery technology, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical needs. For more information, visit www.tranzyme.com.
Norgine is an independent, successful 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 EURO250 million. The company employs over 1,000 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. For more information, visit www.norgine.com.
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