Idenix Pharmaceuticals has reported the positive interim data from a 12-week Phase IIb clinical trial of IDX184, a drug candidate for the treatment for hepatitis C virus infection.
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2′-methyl guanosine. It is being developed under a partial clinical hold.
The drug candidate uses Idenix’s liver-targeting technology to enable the delivery of nucleoside monophosphate. This leads to the formation of high levels of nucleoside triphosphate, maximising drug efficacy and limiting systemic side effects with low, once-daily dosing.
The double-blind and parallel group trial involved treatment-naive genotype 1 HCV-infected patients, who were randomised into two treatment arms, either 50mg or 100mg of IDX184 administered once-daily for 12 weeks. Each arm was administered in combination with pegylated interferon and ribavirin (PegIFN/RBV).
In the 100mg IDX184 arm, 73% of patients achieved a rapid virologic response and 87% had undetectable virus, while in the 50mg IDX184 arm, 63% of patients achieved and 94% had undetectable virus.
Following 28 days of treatment, the first 31 patients showed that IDX184 was well-tolerated without showing any serious adverse events associated with therapy.
Eric Lawitz of Alamo Medical Research,Camden Medical Center, said that the interim results confirm the antiviral activity and safety of IDX184 in combination with pegylated interferon and ribavirin.
”Eventually, the goal for treatment will be to reduce or eliminate reliance on interferon and to shift to all oral combinations of direct-acting antiviral agents that can reduce potential side effects and decrease the amount of time on therapy," Lawitz said.
In both pre-clinical and clinical studies, IDX184, a pan-genotypic oral nucleotide polymerase inhibitor, has demonstrated a high barrier to resistance in vitro and potent antiviral activity.
The company has submitted the interim data and the Data Safety Monitoring Board’s recommendations, to the US Food and Drug Administration, requesting the continuation of the study and removal of the partial clinical hold for IDX184.