Vertex Pharmaceuticals Inc. (VRTX: Quote) Monday revealed positive results from an early-stage viral kinetic study of the nucleotide analogue ALS-2200 for the treatment of hepatitis C.
As per the study results, there was a median 4.54 log10 reduction in hepatitis C virus (HCV) RNA in people with genotype 1 chronic hepatitis C who were new to treatment after seven days of dosing with 200 mg of ALS-2200 once daily. ALS-2200 was well-tolerated and no patients discontinued due to adverse events.
Vertex said that based on the positive data, it plans to begin Phase 2 studies this year of 12-week all-oral regimens including ALS-2200 in people with genotype 1 hepatitis C, pending discussions with regulatory agencies.
Vertex said it plans conduct a study to assess ALS-2200 in combination with Incivek (telaprevir), the company's approved protease inhibitor for people with genotype 1 hepatitis C, and a study of ALS-2200 in combination with ribavirin.
These studies will evaluate 12 total weeks of treatment with a primary endpoint of SVR12 (sustained viral response: undetectable hepatitis C virus 12 weeks after the end of treatment) in people with genotype 1 hepatitis C.
Also today, Vertex reported a smaller quarterly loss on a surge in sales. It however slashed its full-year 2012 revenue expectations for Incivek, citing the recent downward trend in the number of patients initiating treatment within the hepatitis C market.
VRTX closed Monday at $49.96, up 1.30%, on a volume of 2.2 million shares on the Nasdaq. In after hours, the stock rallied $3.04 or 6.08%.
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by RTT Staff Writer
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