The confirmatory Phase III trial is a 400-patient, multi-center, double-blind, randomized, placebo-controlled study conducted in 48 centers in North America and Europe. It is designed to confirm the results of the first Phase III trial by examining the safety and efficacy of a daily administration of 2mg of tesamorelin for a period of 26 weeks as well as the long-term safety over a period of 52 weeks.
Positive 26- and 52-week results of the first Phase III trial were respectively announced in December 2006 and in October 2007. Positive 26-week results from the confirmatory Phase III trial were disclosed in June 2008. To date, all results have shown tesamorelin’s ability to selectively reduce excess abdominal fat in patients with HIV-associated lipodystrophy while being well tolerated, the company said.
The company now expects to be in a position to present top-line 52-week results of this confirmatory Phase III trial by the end of 2008.
Yves Rosconi, president and CEO of Theratechnologies, said: “With the treatment of the last patient in the Phase III program and the 52-week results expected by year end, we believe that we will be in a good position to optimize the product monograph for tesamorelin. After the 52-week results are announced, we will complete our regulatory file in order to submit it to the FDA. We are targeting to obtain regulatory approval around the end of 2009.”