Idenix gains on CV safety data for IDX184

Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) gained $0.48 (12%) to $4.65 on Monday after reporting that once-daily 50 and 100 mg IDX184 plus pegylated interferon and ribavirin for 12 weeks showed no evidence of severe cardiac findings in a Phase IIb trial to treat HCV infection. Cardiac safety measurements included electrocardiograms, echocardiograms and levels of the cardiac biomarkers N-terminal pro-brain natriuretic peptide (NT-proBNP) and ultra-sensitive troponins. The double-blind, international trial enrolled 67 treatment-naïve patients with HCV genotype 1 infection. Data were presented at the American Association for the Study of Liver Diseases meeting in Boston.

In September, Idenix received formal FDA letters related to clinical holds for IDX184 and fellow HCV product IDX19368. For IDX184, FDA asked the company for an external cardiology expert review, as well as clinical data from echocardiograms and cardiac biomarker studies, including NT-proBNP and ultra-sensitive troponins. The agency also asked for a risk management plan for cardiac monitoring in future clinical trials. ...