Left on FDA 'hold,' Idenix hangs up on once-hot hep C drugs
For the past few weeks Idenix ($IDIX) has been methodically moving away from its once-promising hepatitis C drugs, put on clinical hold by a jittery FDA in the wake of a catastrophic trial of a somewhat similar drug at Bristol-Myers Squibb ($BMY). On Monday afternoon the two programs, including the once-hot "nuc" IDX184, were shelved and locked away as the biotech decided the time had come to move decisively in a new direction.
Idenix's woes came as a nasty shock to investors after the cardiac adverse events experienced in the Phase II study of BMS-986094 painted the biotech's 2′-methyl guanosine nucleotide prodrugs with the same brush of fear. Late last year Idenix completed the submission of requested cardiac safety data to the FDA, but the FDA remained unmoved in recent days, making the decision to terminate the work a foregone conclusion.
"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 Idenix CEO Ron Renaud in a release. "We are completing IND-enabling studies for a uridine nucleotide analog, which is in a subclass 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."
The focus at Idenix shifts to the NS5A inhibitor IDX719, which is being pushed quickly into midstage studies.
"In January 2013, we entered into a non-exclusive collaboration with Janssen Pharmaceuticals for the development of all-oral direct-acting antiviral HCV combination therapies incorporating IDX719," says Renaud. "Following an initial drug-drug interaction study to begin in the first quarter of 2013 and pending approval from regulatory authorities, we expect to begin the first phase II study under this program of a two-DAA regimen, including IDX719."
- here's the press release
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