Norgine and Tranzyme Pharma complete enrolment for new TZP-101 trial

Norgine and Tranzyme Pharma have completed enrolment for a new clinical trial of TZP-101, a treatment that aids gastrointestinal recovery among patients undergoing abdominal surgery.

Around 330 bowel surgery patients have been enrolled at sites across the US and Europe for the Ulises 008 study, which will assess the safety and efficacy of TZP-101 compared to placebo.

It is the second of two trials that make up the phase III assessment programme for the new compound, with enrolment for the accompanying Ulises 007 study having been completed in December 2011.

The companies are hoping to file for regulatory approval of their drug before the end of the year.

Dr Franck Rousseau, chief medical officer of Tranzyme Pharma, said: "We are very pleased with the timely completion of enrolment in our second phase III trial and expect to release top-line results of both trials in the first half of 2012."

In January 2012, Norgine announced a new agreement with APR and Labtec that will provide it with European distribution rights to Setofilm.