ANA598 To Be Dosed for 12 Weeks in Triple Combination
SAN DIEGO, July 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced finalization of the protocol for the Company's 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 United States Food and Drug Administration (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(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 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 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR).
Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen receiving placebo at each dose level. The study will be conducted at a number of clinical sites in the United States. Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.
"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," said Steve Worland, Ph.D., President and CEO of Anadys. "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."
About ANA598
ANA598 is a non-nucleoside inhibitor of the HCV RNA polymerase.
