Theratechnologies fills TH9507 phase 3 trial studying HIV-related complication

By Elaine Rigoli

Tampa, Fla., March 23 - Theratechnologies announced Thursday that it has completed patient enrollment for its first phase 3 clinical trial using TH9507 for the treatment of HIV-associated lipodystrophy.

The multi-center, double-blind, randomized, placebo-controlled study will be conducted in about 40 centers in the United States and Canada, according to a company news release.

The study is examining the safety and efficacy of a daily administration of 2 mg of TH9507 for 26 weeks.

The primary endpoint is a reduction of visceral adipose tissue, which is a risk factor for cardiovascular disease and type 2 diabetes, the release said.

There is no approved treatment for excess abdominal fat in HIV-associated lipodystrophy, a condition that affects a substantial percentage of HIV patients.

It is characterized by major physical changes - notably abdominal fat accumulation and/or loss of peripheral subcutaneous fat - as well as lipid and carbohydrate disorders (high cholesterol and blood sugar), conditions that can foster cardiovascular disease and type 2 diabetes.

Such abnormalities may also discourage compliance with HIV regimens, the release said.

Theratechnologies is a Montreal, Quebec-based biopharmaceutical company that discovers or acquires innovative drug candidates in order to develop them and bring them to market.

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