IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2′-methyl guanosine, and is currently being developed under a partial clinical hold.
The randomized, double-blind parallel group Phase IIb clinical trial included treatment-naive genotype 1 HCV-infected patients, who were treated with either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks.
The study demonstrated that 73% of patients in the 100 mg IDX184 arm and 63% in the 50 mg arm had undetectable virus at 28 days, while 87% of patients in the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a median of 8 weeks of treatment.
Camden Medical Center Alamo Medical Research professor Eric Lawitz said the interim results confirm the antiviral activity and safety of IDX184 in combination with pegylated interferon and ribavirin.
Idenix has submitted the interim data and the Data Safety Monitoring Board’s (DSMB) recommendations, to the US Food and Drug Administration (FDA), requesting the continuation of the study and removal of the partial clinical hold for IDX184.