ALS-2200: Additional Phase I data

Data from a cohort of 8 treatment-naïve patients with chronic HCV genotype 1 infection in a double-blind, placebo-controlled, international Phase I trial showed that once-daily 200 mg ALS-2200 plus ribavirin reduced median HCV RNA levels by 4.18 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) and 2 of the 5 achieved HCV RNA levels below the limit of detection. ALS-2200 was well tolerated with no serious adverse events reported. Data will be presented at the American Association for the Study of Liver Diseases meeting in Boston in November.

The partners previously reported data from 40 treatment-naïve patients with chronic HCV genotype 1 infection showing that median reductions in HCV RNA levels from baseline to day 7 were 0.97 log10 IU/mL for once-daily 15 mg ALS-2200, 3.02 log10 IU/mL for once-daily 50 mg ALS-2200, 3.95 log10 IU/mL for once-daily 100 mg ALS-2200 and 4.54 log10 IU/mL for once-daily 200 mg ALS-2200 vs. an increase of 0.11 log10 IU/mL for placebo (see BioCentury, Aug. 6). By year end, Vertex plans to start a pair of Phase II trials evaluating 12-week regimens of ALS-2200 given in combination with Incivek telaprevir or ribavirin, respectively. ...