The company said that the cause of death and the relationship of the study drug, known as DAC:GRF, to the event, which occurred at a clinical site in Argentina, is currently under investigation.
DAC:GRF, a compound employing the growth hormone releasing factor (GRF) peptide, was being evaluated in a once-weekly dosing regimen in 192 patients. The study design consists of 12-weeks of treatment followed by a 6-week follow-up.
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.
In addition to lipodystrophy associated with HIV, ConjuChem previously said that it intends to develop DAC:GRF in other indications for adult patients and in growth hormone (GH) deficiency in children.