Please login to the form below

Not currently logged in
Email:
Password:

Tranzyme drops lead drug on phase III disappointment

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.

Contact:

Phone:

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Blue Latitude

We are experts in customer engagement. A strategic multichannel marketing and customer experience agency, specialising in pharmaceuticals, medical devices, and...

Latest intelligence

McCann.jpg
The heart of the matter: Part Two
How is social media impacting publication planning?...
digital numbers
Seven steps to innovating your digital strategy
Dealing with digitally native HCPs...
Online Physician Communities
Online learning increasingly popular for doctors
Sponsorship can help companies raise their profile specific therapy areas...