BioCentury
ARTICLE | Clinical News

ALS-2200: Additional Phase I data

April 29, 2013 7:00 AM UTC

Data from a cohort of 8 treatment-naïve patients with chronic HCV genotype 3 or 4 infection in a double-blind, placebo-controlled, international Phase I trial showed that once-daily 200 mg VX-135 as monotherapy reduced median HCV RNA levels by 4.65 log10 IU/mL from baseline to day 7. Additionally, 5 patients in the cohort achieved HCV RNA levels below the limit of quantification (<=25 IU/mL). One treatment-naïve patient with chronic HCV genotype 2 infection achieved a median reduction in HCV RNA levels of 5.04 log10 IU/mL from baseline after receiving once-daily 100 mg VX-135 for 7 days. Furthermore, once-daily 200 mg VX-135 as monotherapy reduced median HCV RNA levels by 4.08 log10 IU/mL from baseline to day 7 in a cohort of 8 treatment-naïve patients with chronic HCV genotype 1 infection and compensated cirrhosis. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam. Vertex previously reported data from treatment-naïve patients with chronic HCV genotype 1 infection in the trial (see BioCentury, Aug. 6, 2012 & Oct. 1, 2012).

Vertex has exclusive, worldwide rights to VX-135 from Alios under a 2011 deal (see BioCentury, June 20, 2011). Earlier this month, Vertex said it will conduct a pair of Phase II trials evaluating once-daily oral treatment regimens containing VX-135 in combination daclatasvir from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). Vertex plans to start the first trial this quarter in about 20 non-cirrhotic, treatment-naïve patients with HCV genotype 1 infection and the second trial next half in 250 treatment-naïve patients with HCV genotype 1, 2 or 3 infection, including patients with cirrhosis (see BioCentury, April 15). Daclatasvir is a selective HCV NS5A protein inhibitor. ...