IDX184: Development hold

FDA placed a clinical hold on HCV candidates IDX184 and IDX320 due to 3 serious adverse events in a Phase I drug-drug interaction study of the 2 compounds. Idenix said liver function abnormalities were detected in 3 healthy volunteers who received both IDX184, a polymerase inhibitor, and IDX320, a protease inhibitor. The company said liver function has returned to near normal levels in all 3 subjects during follow-up. The double-blind, placebo-controlled trial evaluated 400 mg once-daily IDX320 for week one with 100 mg once-daily IDX184 added on for week two, or 100 mg IDX184 for week one, with 400 mg IDX320 added on for week two in 20 healthy subjects. Idenix, which has yet to receive a formal letter from FDA, plans to submit data from preclinical, toxicology and clinical studies to the agency to assess next steps in the development of both compounds. ...