Idenix Pharmaceuticals announced it has elected not to continue its clinical development program for IDX184, a nucleotide polymerase inhibitor in phase IIb testing for the treatment of hepatitis C virus infection, or to continue its development of IDX19368, an HCV nucleotide polymerase inhibitor for which the company had previously filed an IND but had not initiated patient dosing. In August 2012, the FDA placed IDX184 on partial clinical hold and IDX19368 on clinical hold due to cardiac adverse events seen in a competitor's phase II clinical trial of BMS-986094. In December, Idenix completed the submission of requested cardiac safety data for IDX184 to the FDA. Idenix said it has found no evidence of severe cardiac findings to date. In February, the FDA communicated that the IDX184 and IDX19368 programs would remain on clinical hold, and, as a result, the company has determined it will not continue the development of these programs. Idenix said, "Although we are choosing not to continue our IDX184 and IDX19368 programs, we intend to maintain our strong presence in developing nucleotide polymerase inhibitors for HCV based on our broad discovery platform."
- Pharmaceuticals & Drug Trials