logo
Share SHARE
FONT-SIZE Plus   Neg

Tranzyme Pharma Says ULISES 008 Trial Fails To Meet Primary, Secondary Endpoints

Tranzyme Pharma (TZYM: Quote) and Norgine B.V. announced the results of the primary analysis of ULISES 008, the second of two Phase 3 pivotal trials evaluating ulimorelin in postoperative ileus. Tranzyme Pharma stated that 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 company stated that 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 Rousseau, Chief Medical Officer, Tranzyme Pharma.

"Tranzyme is now focusing its development efforts on TZP-102, an oral ghrelin agonist in Phase 2b for the treatment of diabetic gastroparesis. Diabetic gastroparesis is a chronic upper GI motility disorder and since 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 2b trial are expected by the end of the year," said Franck Rousseau.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
'Booth babes' will not be seen at the RSA Conference scheduled to be held next month, as the exhibitors have added a new clause to its rules that ban revealing clothes. Although, RSA did not use the term "booth babe," its contract clearly explains that staff deployed at booths should wear business... Election fever has gripped the UK as Prime Minister David Cameron on Monday urged his people to prudently choose either a prosperous future under his Conservative Party or economic ruin under the Labour Party headed by Ed Miliband. Fast food giant McDonald's Corp. (MCD), reportedly plans to serve its breakfast menu for the whole day. According to a CNBC report citing analysts from Janney Capital Markets, McDonald's is planning to test serve breakfast for the whole day at select locations starting in the next few months. "Our...
comments powered by Disqus
Follow RTT