Strong safety data on Theratechnologies' tesamorelin

Canada's Theratechnologies presented strong data in a late-breaker presentation on the long-term safety and efficacy of tesamorelin, its growth hormone-releasing factor analog. The primary objective for the study was to evaluate the safety profile of tesamorelin over a 52-week period. The safety profile observed during the 26 to 52 week treatment period is in line with the previously reported 26-week data, but with a lower incidence of adverse events. Consequently, only 3% of patients dropped out because of adverse events during the 26 to 52 week treatment period compared with 12% in the first 26 weeks.

According to the firm, in the second treatment period, the four most commonly reported adverse events were: upper respiratory tract infections (6.5%), nasopharyngitis (5.8%), sinusitis (5.2%), and arthralgia (3.9%). In the first 26 weeks the four most commonly reported adverse events were headache (16%), arthralgia (13%), injection site bruising (9%), and diarrhea/peripheral edema/myalgia (all reported at 8%). In addition, as was the case in the first 26 weeks, no issues related to glycemic control were observed after 52 weeks of treatment.

The drug for HIV-associated lipodystrophy, a condition characterized by a change in the distribution of adipose tissue, dyslipidemia and glucose intolerance, caused an 18% drop in visceral adipose tissue at the end of the study with most VAT loss occurring within the first 26 weeks of treatment.