Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX),
announced that the Company received verbal notice from the U.S. Food
and Drug Administration (FDA) that a clinical hold has been placed on
IDX19368, the Company’s next-generation nucleotide polymerase inhibitor
under development for the treatment of hepatitis C virus (HCV)
infection. This news follows an announcement that Idenix made on August
16, 2012 related to a partial clinical hold placed on IDX184, the
Company’s lead nucleotide polymerase inhibitor also under development
for the treatment of HCV.
The FDA verbally informed Idenix that it placed IDX19368 on clinical
hold due to concerns related to the serious cardiac-related adverse
events reported for HCV patients treated with BMS-986094, a nucleotide
polymerase inhibitor previously under development by Bristol-Myers
Squibb Company. To date, no patients have been exposed to IDX19368.