Idenix Pharmaceuticals,
Inc. IDIX, a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral diseases, today
announced the Company 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 (HCV) 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 U.S. Food and Drug Administration (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. All three
drug candidates are 2′-methyl guanosine nucleotide prodrugs. In December,
Idenix completed the submission of requested cardiac safety data for IDX184 to
the FDA. Idenix 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.
"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's President and Chief Executive Officer. "We are completing
IND-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."
Mr. Renaud continued, "Further, we are pleased with the progress of IDX719,
our potent, pan-genotypic NS5A inhibitor for HCV. In January 2013, we entered
into a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. for the
development of all-oral direct-acting antiviral (DAA) HCV combination
therapies incorporating IDX719. 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."
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