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news.Vertex Pharmaceuticals and Alios BioPharma, together have initiated two clinical studies for the nucleotide analogues ALS-2200 and ALS-2158, inhibitors of the hepatitis C NS5B polymerase.
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ALS-2200 and ALS-2158 are pan-genotypic nucleotide analogues, designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase.
The two Phase 1 studies will be randomized, double-blind, placebo-controlled studies, with the primary goals of evaluating the safety and tolerability of single ascending doses of ALS-2200 and ALS-2158 in healthy volunteers and of multiple ascending doses in people with chronic genotype-1 hepatitis C.
A secondary objective will be to evaluate the effects on viral kinetics of ALS-2200 and ALS-2158 during seven days of dosing in people with hepatitis C.
Vertex holds worldwide development and commercialization rights for ALS-2200 and ALS-2158, which were discovered by Alios BioPharma.
The company is likely to present the data in the second quarter of 2012, which is expected to initiate studies to evaluate multiple all-oral, interferon-free combination regimens for chronic hepatitis C.