SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. today announced that two presentations related to ANA598, the Company’s non-nucleoside polymerase inhibitor in Phase II development for the treatment of hepatitis C, are scheduled for the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010.
Anadys will present preliminary antiviral response and safety results from its ongoing Phase II study of ANA598 in HCV patients, in which ANA598 is being dosed for 12 weeks in combination with pegylated interferon and ribavirin (SOC). For the group receiving ANA598 at 400 mg twice-daily (bid) plus SOC, antiviral response and safety data through eight weeks will be presented, which data further confirm the profile demonstrated for ANA598 at 200 mg bid. Antiviral response and safety data for the complete control group receiving placebo plus SOC will also be updated through eight weeks. Data through 12 weeks will be presented for the group that received ANA598 200 mg bid plus SOC.
Anadys will present preclinical data showing enhanced activity and suppression of resistance when ANA598 is combined in vitro with other anti-HCV agents.
Phase II Combination Study
In the ongoing Phase II study, treatment-naive genotype 1 patients are to receive ANA598 or placebo in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP) for 12 weeks at dose levels of 200 mg bid or 400 mg bid, each with a loading dose of 800 mg bid on day one. After week 12, patients are to continue receiving 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 who achieve undetectable levels of 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 levels of virus at week 4 (defined as Rapid Virological Response, or RVR). Patients will be followed for 24 weeks after stopping therapy to determine the rate of Sustained Virological Response, or SVR. Approximately 90 patients have been enrolled in this study - with approximately 30 patients receiving ANA598 plus SOC at each dose level and 30 patients receiving placebo plus SOC. The study is being managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, M.D. and is being conducted at a number of clinical sites in the United States.
Anadys has completed two long-term chronic toxicology studies of ANA598 (26 weeks duration in rats and 39 weeks duration in monkeys). The No Observed Adverse Effect Level, or NOAEL, is 1000 mg/kg, the highest dose tested, in both the rat and monkey. The completed toxicology studies support the ongoing Phase II clinical study as well as future clinical studies of longer duration.
ANA598 has received Fast Track Status from the FDA for the treatment of chronic hepatitis C.
Pegasys(R) and Copegus(R) are registered trademarks of Hoffman-La Roche Inc.
CONTACT: Investors, Amy Conrad of Anadys Pharmaceuticals, Inc.,
+1-858-530-3607, aconrad@anadyspharma.com; or Media, Ian Stone,
ian.stone@russopartnersllc.com, or David Schull,
david.schull@russopartnersllc.com, both of Russo Partners, LLC,
+1-619-528-2220, for Anadys Pharmaceuticals, Inc.
Web site: http://www.anadyspharma.com/
http://www.easl.ch/
