Cambridge, MA-based Idenix has halted development of two of its investigational therapies for treating hepatitis C viral infection (HCV). The decision follows action taken on the two drugs, IDX184 and IDX19368, by the US Food and Drug Administration (FDA) in the summer of 2012. Both therapies, next generation HCV drugs called nucleotide polymerase inhibitors that prevent HCV from making copies of itself, were associated with potential heart risks.
In August 2012, the FDA placed a partial hold on IDX184 after a patient in a clinical trial for a similar product being tested by Bristol-Myers Squibb died of heart failure. While the FDA reported no heart-related side effects linked directly to the Idenix drug, some heart side effects were reported in patients treated with IDX184 when used in combination with standard hepatitis drugs. The same month, the FDA placed a clinical hold on Idenix’s IDX19368 over the potential for cardiac-related side effects. Clinical trials had not yet begun for IDX19368.
"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," said Ron Renaud, Idenix President and Chief Executive Officer, in a press release. "We are completing IND (investigational new drug)-enabling studies for a uridine nucleotide analog, which is in a sub-class of nucleotide polymerase inhibitors distinct from IDX184, IDX19368 and BMS-986094. We anticipate filing an IND for this next-generation compound during the first half of 2013, and we also plan to continue to advance other preclinical nucleotide prodrugs in earlier-stage development."Source: Bloomberg news, February 4, 2013.