Theratechnologies presents combined Phase 3 results

Theratechnologies (TSX:TH)  presented pooled results from both its phase 3 clinical trials evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy at a conference in Germany.

Treatments with two milligrams of tesamorelin daily for 26 weeks resulted in a significant decrease in visceral adipose tissue, no clinically significant changes in limb fat and a significant decrease in triglycerides, Theratechnologies said in a statement.

At week 52, improvements in visceral adipose tissue and triglycerides were sustained in the group of patients who received the drug over 52 weeks. But in patients who were switched from tesamoreline to placebo at week 26, according to the study design, regained visceral adipose tissue at week 52, it added.

The Montreal-based company submitted a new drug applciation for tesamorelin to the FDA on May 29, 2009.  An advisory committee of the FDA plans to review the NDA.