IDX19368: FDA hold

Idenix said FDA placed a clinical hold on IDX19368, which 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, New York, N.Y.). Last 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 (see BioCentury, Aug. 20). 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.

IDX184, IDX19368 and BMS-986094 are all prodrug forms of the nucleotide 2-methyl-guanosine triphosphate. However, Idenix said its compounds have more favorable toxicity profiles because they use a different prodrug technology. Bristol-Myers subsequently discontinued development of BMS-986094 last month; 1 patient died and 8 others were hospitalized in the trial. Idenix said Bristol-Myers has agreed to share relevant information on BMS-986094 (see BioCentury, Aug. 27). ...