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 - News) 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."
In other words, the way IDIX's compounds are broken down in the body to their active forms may be sufficient to avoid the ill effects seen with the Bristol-Myers' candidate. Bristol has agreed to share study data on BMS-986094 with IDIX, and the company hopes to use this information to resolve issues with the FDA. As part of the partial hold on IDX184, the FDA has requested additional cardiac testing of patients in the company's ongoing Phase IIb clinical trial, and IDIX is conducting echocardiograms on those patients. IDIX expects to submit the results to the FDA in the coming weeks. The company stated that thus far, results have been normal in the small number of patients that were first tested. Expect investors to remain cautious on IDIX until the FDA gives them the all clear on IDX-184 and IDX19368. Achillion Pharmaceuticals (NASDAQ:ACHN - News) is likely to be the beneficiary of the bad news for IDIX - see our prior articlehere.
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