(Montreal, Quebec) Theratechnologies has concluded a Phase 3 trial confirming earlier clinical results on the safety and effectiveness of its lead drug, tesamorelin, for an HIV-related fat disorder.

“With the conclusion of our Phase 3 program in HIV-associated lipodystrophy, we now have a complete profile for tesamorelin,” Theratechnologies CEO Yves Rosconi stated this week.

The findings enable the company to submit a “strong data package” in a new drug application to the U.S. Food and Drug Administration.

HIV-associated lipodystrophy, which causes abdominal fat accumulation and glucose intolerance, is believed to be related to the human immunodeficiency virus and the antiretroviral drugs used against it. There currently is no approved treatment.

Theratechnologies also announced that the U.S. anti-trust waiting period has expired for its collaboration and licensing agreement with EMD Serono Inc., an affiliate of Merck KGaA of Germany.

The deal for American commercialization of tesamorelin was announced in October, providing the Montreal company with US$30 million – a $22-million upfront license fee and an $8-million equity investment at US$3.67 per share.