Anadys Pharmaceuticals announced that it has initiated a Phase 2b study of ANA598 in combination with pegylated interferon and ribavirin for the treatment of hepatitis C (HCV) in both treatment-naive patients and treatment-experienced patients. Anadys had previously presented results from a Phase 2b study of ANA598 in treatment-naïve patients only. In this study, approximately 200 chronically infected genotype 1 hepatitis C patients are expected to receive ANA598 200 mg twice a day in combination with Pegasys (peg interferon alfa-2a, from Roche) and Copegus (ribavirin, from Roche) (a current standard of care, or SOC) with a loading dose of 800 mg twice daily on day 1, while approximately 66 patients are to receive placebo and SOC. Enrollment is expected to include approximately equal numbers of treatment-naive patients and patients who have failed a prior course of SOC, including difficult to treat prior null-responders. The primary endpoint of the study is Sustained Virological Response (SVR) 24 weeks after patients conclude all treatment, known as SVR24.
ANA598 is a non-nucleoside polymerase inhibitor being developed as a direct-acting antiviral (DAA) for the treatment of chronic hepatitis C virus (HCV) infection.
For more information call (858) 530-3600 or visit www.anadyspharma.com.