Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that ANA598 dosing has been completed in the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients. Anadys expects to receive 12-week safety and antiviral response data for the 200 mg bid cohort in the first quarter of 2010. Anadys also announced that all patients have commenced dosing in the second dose cohort, 400 mg bid. With patient enrollment in this cohort completed, Anadys has accelerated the expected timing to receive 4-week safety and antiviral response at 400 mg bid to the end of the first quarter of 2010 and continues to expect 12-week safety and antiviral response data in the second quarter of 2010.
"We are very pleased with the rapid progress of this study and appreciate the commitment of everyone involved in the trial," said Steve Worland, Ph.D., President and Chief Executive Officer of Anadys. "With continuing positive data, we hope to see ANA598 established as the leading non-nucleoside in HCV, suitable for combination with current standard of care as well as with other direct antivirals currently in development."
Phase II Combination Study
Anadys recently reported positive initial antiviral response and safety results from the 200 mg bid dose cohort based on a planned interim analysis of data at four weeks. In the group receiving ANA598 added to SOC, there was a steady increase in the percentage of patients with undetectable levels of virus from week 1 through week 4, with 56% of patients achieving undetectable levels of virus at week 4 (defined as Rapid Virological Response or RVR), compared to 20% of patients receiving placebo plus SOC achieving an RVR. No patient receiving ANA598 experienced viral rebound (defined as >1 log(10) increase from a prior measurement) through week 4. ANA598 also demonstrated a favorable safety profile through four weeks. There were no serious adverse events reported and the profile of adverse events reported was as expected for patients receiving SOC alone, with comparable rates observed between the ANA598 and placebo arms.