IDIX Under Pressure As Second Hep C Compound Is Placed On FDA Hold

After receiving word from the FDA that lead hepatitis C (HCV) treatment candidate, IDX-184, was placed on partial clinical hold as of mid-August, Idenix Pharmaceuticals (NASDAQ:IDIX) announced this morning that the company received verbal notice from the agency that IDX-19368 was also placed on clinical hold. This means that neither compound can advance in clinical development unless the FDA has reviewed safety data and agrees that there is no cardiovascular risk, as with Bristol-Myers’ similar compound BMS-986094, which was recently discontinued from development.  According to IDIX, no patients have been exposed to IDX-19368, and management recently stated that it has not observed cardiac events with IDX-184. While both IDX-184 and IDX-19368 share the same active metabolite as BMS-986094, IDIX management says, “There are many attributes of our compounds, particularly the prodrug approach, that we believe favorably differentiate the toxicity profiles from that of BMS-986094.” (more…)