The randomised double-blind placebo-controlled Phase 1a/1b clinical trial will evaluate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2928.
The clinical study includes three segments: assessment of single ascending oral doses (SAD) in healthy volunteers, evaluation of 3 days of oral repeat doses in subjects with genotype 1a or 1b HCV, and a 5-day multiple ascending doses segment in healthy volunteers.
The Phase 1b trial has demonstrated that patients treated with ACH-2928 achieved a mean maximum 3.68 log10 reduction in HCV RNA after a three-day monotherapy of 60 mg once daily.
The preliminary data from the SAD trial segment showed the tolerability of ACH-2928 at all doses evaluated up to and including the maximum dose of 500 mg with no serious adverse events.
Achillion chief scientific officer Milind Deshpande said along with the Phase I study of ACH-2928, the company is also planning to advance ACH-3102, which has shown in preclinical studies to possess the same potent activity against genotype 1a HCV as ACH-2928.
"We believe these results validate our NS5A development program, and look forward to developing an all-oral combination for clinical evaluation that includes one of our protease inhibitors and an NS5A inhibitor next year," Deshpande added.