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News Breaks | | | | September 26, 2012 | | 07:51 EDT |  | VRTX | Vertex said ALS-2158 activity insufficient to proceed with development
Vertex Pharmaceuticals (VRTX) and its collaborator Alios BioPharma yesterday morning announced results from a viral kinetic study of the adenosine nucleotide analogue pro-drug ALS-2158 for the treatment of hepatitis C. Data showed that seven days of dosing with up to 900 mg of ALS-2158 was well-tolerated in people with genotype 1 chronic hepatitis C, but that there was insufficient antiviral activity to warrant proceeding with further clinical development. The companies also announced new data from an additional cohort of an ongoing viral kinetic study of the uridine nucleotide analogue pro-drug ALS-2200 in combination with ribavirin. There was a median 4.18 log10 reduction from baseline in HCV RNA after seven days of dosing with a once-daily 200 mg dose of ALS-2200 in combination with ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. Five patients achieved HCV RNA levels below the limit of quantification and two of these five achieved HCV RNA levels below the limit of detection after seven days of treatment. Similar to previously announced data from the monotherapy cohort, ALS-2200 was well-tolerated, no patients discontinued due to adverse events and there were no serious adverse events, the companies said. Pending discussions with regulatory agencies, Vertex is planning one Phase 2 study to evaluate ALS-2200 in combination with ribavirin, and one to evaluate ALS-2200 in combination with INCIVEK, the company’s approved protease inhibitor for people with genotype 1 chronic hepatitis C. | |
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| May 10, 2013 | | 14:02 EDT |  | VRTX | Vertex to benefit from Welsh government decision, says Wells Fargo
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