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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and its collaborator Alios BioPharma, Inc. today announced positive results from a viral kinetic study of the nucleotide analogue ALS-2200 for the treatment of hepatitis C. There was a median 4.54 log
10 reduction in hepatitis C virus (HCV) RNA in people with genotype 1 chronic hepatitis C who were new to treatment (n=8) after seven days of dosing with 200 mg of ALS-2200 once daily. ALS-2200 was well-tolerated in this study, and no patients discontinued due to adverse events. Based on these data, Vertex 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.
Patients with hepatitis C dosed with ALS-2200 in this study had a dose-dependent, consistent and rapid decline in HCV RNA. After three days of dosing, a median 3.85 log
10 decline was observed among patients in the 200 mg dose group. In this dose group, a median 4.54 log
10 decline was observed after seven days of dosing, which was maintained for up to two days after the completion of dosing. Four of eight patients in this dose group achieved HCV RNA levels below the limit of quantification (<LOQ = < 25 IU/mL). There were no serious adverse events observed in people dosed with ALS-2200 in the study. Data from this study have been submitted to a medical meeting for presentation in the second half of this year.
Based on these data, Vertex expects to conduct a study to evaluate 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.
“We’re encouraged by the substantial, rapid and consistent viral decline and initial safety results from this study, which make ALS-2200 a very promising part of Vertex’s hepatitis C pipeline,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “ALS-2200, with its high level of antiviral activity, gives us flexibility to explore several combinations of all-oral treatment regimens for hepatitis C. We’re moving quickly to begin the first Phase 2 trials this year.”