Idenix Pharmaceuticals Initiates Enrollment in Phase II Study of Samatasvir, Simeprevir, TMC647055 for Treatment of Hepatitis C
Idenix Pharmaceuticals (Nasdaq: IDIX) today announced the initiation of patient enrollment in the phase II HELIX-2 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir, Idenix's once-daily pan-genotypic NS5A inhibitor, simeprevir, a once-daily NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and TMC647055, a once-daily NS5B non-nucleoside polymerase inhibitor boosted with low-dose ritonavir developed by Janssen.
The HELIX-2 trial is a 12-week, randomized, open-label study evaluating the efficacy, safety and tolerability of samatasvir, simeprevir, and TMC647055. The trial will evaluate genotype 1 HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 50 mg samatasvir, 75 mg of simeprevir and 450 mg of TMC647055/ritonavir (30 mg), each once daily for 12 weeks, with or without ribavirin.
The HELIX-2 trial is the second study in HCV-infected patients to commence under a non-exclusive collaboration agreement signed with Janssen in January 2013. The HELIX-1 trial of samatasvir in combination with simeprevir was initiated in May 2013 and is ongoing.