Anadys Obtains FDA Clearance For Phase II Protocol To Study ANA598

Anadys has received FDA clearance for its phase II protocol to study ANA598, in combination with pegylated interferonalpha and ribavirin, in hepatitis C patients.

In the study, naive genotype 1 patients will receive ANA598 or placebo, in combination with Pegasys and Copegus, for 12 weeks at dose levels of 200mg or 400mg twice daily (bid), each with a loading dose of 80mg bid on day one.

Reportedly, 90 patients are planned to be enrolled in this study – 30 patients receiving ANA598 and 15 receiving placebo at each dose level.

Anadys expects to receive 28-day safety and response (RVR) data from the 200mg dose level by year-end, and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.

Steve Worland, president and CEO of Anadys, said: “ANA598 has demonstrated potent antiviral activity and good tolerability as a single agent in Phase I, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens.

“We are now in a position to demonstrate the value of ANA598 when used in combination in a Phase II trial to treat hepatitis C patients. This trial incorporates several attractive features designed to further enhance the competitive position of ANA598, including twelve weeks of triple combination treatment and a randomized exploration of shortening the overall duration of HCV therapy in conjunction with ANA598 treatmen,” he added.