Theratechnologies Inc (TH.TO) said on Monday that the 52-week results from Phase 3 trials of its HIV lipohypertrophy treatment, tesamorelin, delivered even better results than its half-year results, buoying hopes that the treatment would eventually see key U.S. approval.
The strong results, coupled with the increased optimism of the approval, pushed the shares of the small biotechnology company up more than 10 percent.
Theratechnologies said patients given tesamorelin (TH9507), designed to treat a disease that increases central fat accumulation in the body of HIV-infected patients, lost 18 percent of their visceral adipose tissue (VAT).
This compares with 15 percent for patients for the first 26 weeks. Also, patients treated with tesamorelin for 26 weeks followed by a placebo for 26 weeks regained VAT to levels comparable to baseline values.
The tests also showed there didn't appear to be a significant impact on glucose tolerance, which is key to the approval of the treatment.
"The long-term safety profile is very encouraging and is virtually unchanged from the safety profile observed after 26 week of treatment," Yves Rosconi, president and chief executive, said during a conference call.
Shares of Theratechnologies were up C$1.04, or 9.6 percent, at C$11.90 by late morning, after rising as high as C$12.25.
Last month the company said the FDA was reassured that there were no signals of glucose intolerance or other safety concerns, which prompted it to indicate that additional clinical outcome trials beyond the current Phase 3 trials already in progress would probably not be needed.
beating Insmed to market by 2 years is bad news indeed.Market penetration often takes a few years. (btw - HARS 300 M is 20% estimate which is HIGH by any standard of a population). and is this why TRCA and oters are leery about Insmed s hard indication for their timeframe? and why Insmed HARS is all risk to Insmed until they get to Phase 3 ? Tericia is very clever indeed