Idenix Pharmaceuticals, Inc. : Idenix Announces Removal of the Partial Clinical Hold on HCV Nucleotide Inhibitor, IDX184
CAMBRIDGE, Mass., Feb. 3, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the partial clinical hold on IDX184 has been removed and that the Company's 12-week phase IIb study evaluating IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV) may continue. IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection is a pan-genotypic oral nucleotide polymerase inhibitor, and has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies. Recently announced interim phase IIb data demonstrated favorable antiviral activity and no serious adverse events.
"After review of the interim safety and antiviral activity results from the IDX184 phase IIb clinical trial, the FDA removed the partial clinical hold and has allowed us to continue enrollment of this study," Ron Renaud, President and Chief Executive Officer of Idenix, commented. "Importantly, this allows us to expand the phase IIb program and evaluate IDX184 in interferon-free combination regimens with other direct-acting antivirals. We are working toward beginning all-oral combination trials as quickly as possible."
