Ulimorelin fails to show efficacy for hastening recovery in patients undergoing abdominal surgery
Tranzyme Pharma has halted development of its ulimorelin drug for hastening recovery in patients undergoing abdominal surgery after it failed to show efficacy in a phase III trial.
Ulimorelin failed to meet both primary and secondary endpoints in the ULISES 007 trial, the first of two that were underway for the drug. The company had earlier said it planned to file for approval of ulimorelin in the US by the end of the year.
Ulimorelin is an intravenous ghrelin agonist that was being evaluated for its ability to accelerate gastrointestinal recovery in patients undergoing abdominal surgery.
The main outcome measure in the trial was time to recovery of gastrointestinal (GI) function defined as the time to the later of first bowel movement and tolerance of solid food.
Tranzyme's chief executive Vipin Garg said the company would continue to analyse the trial data but added "we are stopping all other NDA [New Drug Application] activities for ulimorelin".
The results are also a disappointment for Dutch pharma company Norgine, which licensed rights to ulimorelin outside North America and Asia from Tranzyme in 2010, in a deal involving an upfront payment of $8m and up to $150m in milestones.
The failure leaves Tranzyme focusing its efforts on TZP-102, an oral ghrelin agonist for diabetic gastroparesis (delayed stomach emptying), which is currently in phase IIb testing. Data from this study should be available by the end of the year, according to Garg.
The company ended 2011 with around $41m in cash and reported over $30m in operating expenses last year, although its cash use will reduce significantly with the termination of the phase III programme.
Last month Tranzyme raised another $9m in debt financing, saying at the time that this would allow it to cover expenses into the fourth quarter of 2013.