UPDATE 1-Theratech gets good results in drug trial
TORONTO, June 18 (Reuters) - Theratechnologies Inc (TH.TO) said on Wednesday it received positive results in the confirmatory phase 3 trial of its lead compound tesamorelin to treat the increase of central fat accumulation in HIV-infected patients.
Patients treated with the drug for 26-weeks showed an average 10 percent decrease in visceral adipose tissue compared with patients who received the placebo.
Patients also saw a significant improvement in belly appearance distress compared with the placebo group. This was considered to be an important endpoint because of the implications for patient adherence, the company said.
Theratechnologies said the study met its primary endpoint of VAT reduction, as well as important secondary endpoints, and confirmed the positive results of the initial phase 3 study.
"These confirmatory data are critical to the New Drug Application submission that is in preparation to obtain market approval for tesamorelin," Chief Executive Yves Rosconi said in a statement.
HIV-associated lipodystrophy can be caused by several factors including the patient's antiviral drug regimen or the virus itself. The condition causes changes in body composition including the accumulation of abdominal visceral fat and the loss of subcutaneous fat in the limbs and face. (Reporting by Leah Schnurr; Editing by Scott Anderson)
