Biopharmaceutical company Idenix Pharmaceuticals Inc (IDIX) Friday announced that it has received notification from the U.S. Food and Drug Administration, or the FDA, that the partial clinical hold on IDX184 has been removed.
The Company further added that its 12-week phase IIb study evaluating IDX184 in combination with pegylated interferon and ribavirin 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.
Ron Renaud, President and Chief Executive Officer of Idenix, commented , "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."
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