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news.The US Food and Drug Administration (FDA) has lifted partial clinical hold on Idenix Pharmaceuticals' IDX184 and approved to continue the 12-week Phase IIb study evaluating IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV).
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IDX184 is a pan-genotypic oral nucleotide polymerase inhibitor, used for the treatment of hepatitis C virus (HCV) infection.
In September 2010, FDA has issued a clinical hold as a result of three cases of elevated liver function tests observed during a drug-drug interaction study in healthy volunteers of the combination of IDX184 and IDX320.
Idenix CEO and president Ron Renaud said following 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 to continue enrollment of this study.
"Importantly, this allows us to expand the phase IIb program and evaluate IDX184 in interferon-free combination regimens with other direct-acting antivirals," Renaud added.
In preclinical and clinical studies, as well as in interim Phase IIb study, IDX184 has demonstrated a high barrier to resistance in vitro and potent antiviral activity.
IDX184 includes Idenix’s proprietary liver-targeting technology that enables the delivery of nucleoside monophosphate to the liver, maximising drug efficacy and limiting systemic side effects with low, once-daily dosing.