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ARTICLE | Clinical News

AL-335: Interim Phase IIa data

October 3, 2016 7:00 AM UTC

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN, New Haven, Conn.) reported interim data from 4 cohorts of treatment-naive patients with chronic HCV genotype 1 infection in an open-label, New Zealand Phase IIa trial evaluating oral combinations of AL-335, odalasvir and Olysio simeprevir. In cohort 1 (n=20), once-daily 400 mg AL-335 plus 50 mg odalasvir and 100 mg Olysio simeprevir for 8 weeks led to an SVR 24 weeks after the end of treatment in 100% of patients. In cohort 2 (n=20), once-daily 800 mg AL-335 plus 50 mg odalasvir given every other day for 8 weeks led to an SVR12 rate of 90%. In cohort 3 (n=20), once-daily 800 mg AL-335 plus 50 mg odalasvir given every other day and once-daily 75 mg Olysio for 8 weeks led to an SVR4 rate of 100%. In cohort 4 (n=20), once-daily 800 mg AL-335 plus 50 mg odalasvir given every other day and once-daily 75 mg Olysio for 6 weeks led to an end of treatment response rate of 100%. The trial is enrolling about 140 treatment-naive patients with chronic HCV genotype 1 or 3 infection. The combination will also be evaluated in a Phase IIb trial in treatment-naive and treatment-experience patients with chronic HCV genotype 1, 2, 4, 5 or 6 infection without cirrhosis. ...