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.