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news.Canadian-based Theratechnologies has reported positive results for a phase III trial testing its lead compound, TH9507, in patients with HIV-associated lipodystrophy, a side-effect of HIV medications.
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HIV-associated lipodystrophy is characterized by major physical changes as well as lipid and carbohydrate disorders, conditions that can foster cardiovascular disease and type 2 diabetes. Patient discomfort with such abnormalities may also discourage compliance with HIV regimens.
The study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. After 26 weeks, patients on TH9507 achieved a 15% reduction in VAT versus baseline and a 20% difference versus placebo. Further, TH9507 was shown to be well tolerated by patients and the safety profile was in line with what has been seen in Theratechnologies’ previous studies.
“The next step is to confirm these results through a second study. The preparations for the new study in North America and Europe are well advanced and we expect to enroll our first patients during the first quarter of 2007,” said Yves Rosconi, president and CEO of Theratechnologies.