MONTREAL - Theratechnologies Inc. (TSX:TH) 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.
Patients lost 18 per cent of their excess visceral fat after 52 weeks of treatment, after shedding 11 per cent in 26 weeks.
"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 Monday.
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 Monday 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 licence fee and an $8-million equity investment at US$3.67 per share.
Theratechnologies stock traded Monday morning at C$1.75, up six cents on the Toronto Stock Exchange session, with a 52-week high and low of $12.00 and $1.05.
