Montreal-based Theratechnologies announced today that the last patient enrolled in its confirmatory Phase III clinical trial of tesamorelin for HIV-associated lipodystrophy has completed 26 weeks of treatment. The press release from the company also suggests that data from the first six months of the yearlong study will be released within the next few months.
The clinical trial currently under way was designed to confirm the results of the first Phase III study by examining the safety and efficacy of daily injections of 2 mg tesamorelin for 26 weeks. Data from the first study, reported in a December 2007 issue of The New England Journal of Medicine, indicated that tesamorelin treatment for six months decreased visceral adipose tissue (VAT)—deep belly fat—by 15 percent, compared with a 5 percent increase in VAT among those who received placebo injections.
Improvements in triglyceride and cholesterol levels were also reported in the first Phase III study.
“We are extremely pleased to have completed our confirmatory Phase III trial on schedule,” Dr. Christian Marsolais, vice president of clinical research at Theratechnologies, is quoted as saying in the press release. “These data will allow us to move forward with the preparation of the documentation required to submit a New Drug Application for tesamorelin [for the treatment of] HIV-associated lipodystrophy to the U.S. Food and Drug Administration by year end.”
Allowing for a standard 10-month review period, tesamorelin could be available for commercial use in the U.S. by mid-2009.
