Anadys Receives FDA Clearance For Phase II Protocol To Study ANA598

Anadys has announced finalization of the protocol for its phase II trial of ANA598, in combination with pegylated interferon-alpha and ribavirin, in hepatitis C patients. Allowance of the protocol has been received from the FDA, and patient dosing is expected to commence within the next several weeks.

In the phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (SOC) for 12 weeks at dose levels of 200mg or 400mg twice daily (bid), each with a loading dose of 800mg bid on day one. After week 12, patients will continue to receive SOC, said the company.

Patients who achieve undetectable levels of virus at weeks four and 12 will be randomized to stop all treatment at week 24 or 48. The primary endpoint of the study is the proportion of patients with undetectable virus at week 12. Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week four, weeks 24 and 48, and 24 weeks after stopping all treatment.

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

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 treatment, he added.