Lipodystrophy is a condition dominated by fat redistribution, particularly visceral fat accumulation and subcutaneous fat loss. No drugs are currently approved for the treatment of HIV lipodystrophy.
According to the company, it is estimated that of the 500,000 HIV patients treated with HAART, 200,000 of them have lipodystrophy.
DAC:GRF, a compound employing the growth hormone releasing factor (GRF) peptide, is being evaluated in a once-weekly dosing regimen.
The primary endpoint of the study is the change in IGF-1 levels from baseline to week 12. Secondary endpoints include changes in visceral adipose tissue (VAT) and subcutaneous adopise tissue (SAT) (as measured by CT scan), lean body mass, body composition (as measured by DEXA scan), weight and body image assessment.
192 patients were randomized to a low-dose cohort (3-week escalating titration at 60, 90, 120mcg/kg), a high-dose cohort (3-week escalating titration at 60, 120, 240mcg/kg) or a placebo cohort. Each cohort is dosed once a week. The study duration is 12-weeks of treatment followed by a 6-week follow-up and a 3-month open label study extension planned at the end of this study.
In addition to lipodystrophy associated with HIV, ConjuChem intends to develop DAC:GRF in other indications for adult patients and in growth hormone (GH) deficiency in children.