BioCentury
ARTICLE | Company News

FDA places hold on second Idenix HCV compound

August 28, 2012 12:29 AM UTC

Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) said FDA placed a clinical hold on IDX19368, a nucleotide HCV NS5B polymerase inhibitor that was slated to start human testing this quarter. According to Idenix, the agency placed the hold as a precautionary measure following cardiac and renal safety concerns in a Phase II trial of a similar NS5B inhibitor from Bristol-Myers Squibb Co. (NYSE:BMY). Earlier this month, the agency placed a partial clinical hold on Idenix's most advanced HCV product, IDX184, also citing concerns with the Bristol-Myers product, BMS-986094. Idenix said it is performing echocardiograms on 50 patients in the ongoing Phase IIb trial of IDX184, and plans to submit the data to FDA in the "coming weeks." The company added that the echocardiograms completed so far have been normal. ...