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Achillion announces 100-percent SVR in trial evaluating triple combination of odalasvir, AL-335 and simeprevir
NEW HAVEN, Conn.—Achillion Pharmaceuticals Inc. has announced that new interim results from a Phase 2a study being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies, were published as part of the abstracts released for the European Association for the Study of the Liver Special Conference held Sept. 23-24 in Paris.
This ongoing Phase 2a study was designed to confirm the required dose and treatment duration for an all-oral combination regimen containing odalasvir (ODV) and AL-335 with or without simeprevir (SMV) for durations of eight or six weeks of treatment in treatment-naïve patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.
“We are delighted by the significant progress Janssen has made in advancing the all-oral, short-duration treatment regimen of odalasvir, AL-335 and simeprevir and are impressed with the Phase 2a study results being presented. Based on these interim results, Janssen plans to advance a Phase 2b program for the triple combination to further understand the potential of this 3DAA drug combination to shorten the duration of treatment for patients suffering from HCV,” commented Dr. Milind Deshpande, president and CEO of Achillion. “Despite recent therapeutic advances, we believe there remains a significant unmet need in addressing the global burden of hepatitis C virus in those living with the disease.”
Of the 20 patients treated in cohort 1, who received the triple combination of odalasvir, AL-335 and simeprevir for eight weeks, 100 percent remained HCV RNA undetectable 24 weeks after completing therapy. Additional patients were subsequently enrolled into cohorts 3 and 4, where they received adjusted doses of the same triplet combination for either eight or six weeks. In cohort 3 all were HCV RNA negative and remained HCV RNA undetectable four weeks after completing therapy and in cohort 4 all were HCV RNA negative or below the limit of quantitation at end of treatment.
Of the 20 patients treated in cohort 2, who received the dual combination of odalasvir and AL-335 for eight weeks, 90 percent remained HCV RNA undetectable t12 weeks after completing therapy.