THERATECHNOLOGIES REPORTS RESULTS FROM LIPODYSTROPHY STUDY

Theratechnologies has announced positive top-line results for its Phase III clinical trial, testing the company's lead compound, TH9507, in patients with HIV-associated lipodystrophy. The study was powered to detect an 8 percent reduction in visceral adipose tissue (VAT) versus placebo. After 26 weeks, patients on TH9507 achieved a 15 percent reduction in VAT versus baseline and a 20 percent difference versus placebo.

This first Phase III trial enrolled 412 patients in a multicenter, double-blind, randomized, placebo-controlled study conducted in 43 centers in the United States and Canada. The study is examining the safety and efficacy of a daily administration of 2 mg of TH9507 for a period of 26 weeks and long-term safety over 52 weeks. The primary endpoint is a reduction of VAT, which is a risk factor for cardiovascular disease and Type 2 diabetes.

Cholesterol profiles for the active group improved during the 26-week treatment period, denoted by a statistically significant decrease in the total cholesterol to HDL cholesterol ratio, also known as atherogenic index. Triglyceride levels also decreased significantly versus the placebo group.

TH9507 was generally well tolerated by study participants, and the safety profile was in line with what has been seen in Theratechnologies' previous studies. There were no clinically significant differences between the TH9507-treated group and placebo in glycemic control. No patients discontinued the study as a result of glycemic control problems

TH9507, a stabilized analogue of the growth hormone releasing factor (GRF), is aimed at reducing excess abdominal fat or VAT in lipodystrophy patients. There is currently no approved treatment for this condition, which affects an estimated 250,000 HIV-infected patients in North America and Europe.