FDA lifts hold on Idenix's IDX184

Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) said FDA lifted a partial clinical hold on HCV product IDX184 after reviewing interim data from 31 patients in a Phase IIb trial. The biotech now plans to enroll an additional 30 patients in the trial and begin a broad Phase IIb program with IDX184 in the coming months.

The interim data, released last month, showed that 50 and 100 mg IDX184 plus pegylated interferon and ribavirin were well tolerated with no serious adverse events reported. The low- and high-dose arms led to a rapid virologic response (RVR) in 63% and 73% of patients, respectively. IDX184 is a liver targeted prodrug of 2'-methyl guanosine monophosphate (see BioCentury Extra, Jan. 9). ...