Tranzyme Pharma and Norgine Bowel Drug Fails Trial
Published: Mar 12, 2012
"These results are surprising and disappointing. While we are still planning to analyze the data from the second phase 3 trial ULISES 008, which we expect by the end of the second quarter, we are stopping all other NDA activities for ulimorelin," said Vipin K. Garg, Ph.D., President and Chief Executive Officer, Tranzyme Pharma. "We are now focusing on our oral drug TZP-102 which is currently in a phase 2b 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, 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.
Conference Call Details
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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. 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.
About Tranzyme Pharma
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 percent of people in the U.S. are affected by these persistent and recurring conditions which disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options. Tranzyme is developing TZP-102, an oral ghrelin agonist with 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 2b trial is ongoing; top-line data is 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.
Further information about Tranzyme Pharma can be found on the Company's web site at 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 1,200 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. The Company currently markets a range of products in various markets in its key therapeutic areas e.g., MOVICOL(R) for the treatment of constipation and faecal impaction, MOVIPREP(R) a bowel cleansing preparation, KLEAN-PREP(R) for bowel preparation prior to colonoscopy, XIFAXAN(R) for the treatment of travellers diarrhoea and ORAMORPH(R) for the treatment of moderate to severe pain associated with cancer. Norgine is active in research and development and currently has products in various stages of clinical development. Norgine manufactures most of its own products in Hengoed, UK and Dreux, France. For more information: www.norgine.com
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Tranzyme ContactsCorporate Inquiries:Susan SharpeDirector, Corporate Communications(919) firstname.lastname@example.orgInvestor Inquiries:David CareyLazar Partners, Ltd.(212) email@example.comNorgine ContactJulie Hornby WinfieldGlobal Corporate Communications Manager+44 (0) 1895 firstname.lastname@example.org