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news.Anadys Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced that the FDA has granted fast track designation to ANA598 for the treatment of chronic hepatitis C virus infection.
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ANA598 is Anadys’s investigational hepatitis C non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a Phase Ib study evaluating ANA598 for the treatment of patients chronically infected with hepatitis C virus (HCV).
The granting of fast track status for the ANA598 development program is consistent with the need for HCV treatments with novel mechanisms of action, oral administration, non-overlapping resistance profiles and improved safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients, the company said.
James Freddo, chief medical officer of Anadys, said: “The FDA’s fast track designation for ANA598 acknowledges the need for new HCV therapies to improve treatment outcomes. We anticipate continuing to work closely with the FDA on the development and regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors in clinical development for the treatment of HCV.”