Anadys Pharmaceuticals reports positive 4-week results from its ANA598 Phase II study for HCV

Dec 17 2009

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced preliminary results from a planned interim analysis of data at four weeks for the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients. 56% of patients receiving ANA598 plus SOC achieved undetectable levels of virus (<15 IU/ml) at week 4, known as Rapid Virological Response or RVR, compared to 20% of patients receiving placebo plus SOC.

ANA598 was well tolerated through four weeks, with no serious adverse events reported. An independent Data Monitoring Committee (DMC) has endorsed escalating to the second dose level, 400 mg bid, and this cohort is now open for enrollment. Anadys expects to initiate dosing in this cohort in January 2010.

"We are very pleased with the 4-week antiviral response and safety for this first dose cohort," said Steve Worland, Ph.D., President and CEO. "We look forward to the upcoming 12-week data, including antiviral response known as cEVR, for the 200 mg bid cohort in the first quarter of 2010 as well as RVR and cEVR data for the 400 mg bid cohort in the second quarter of 2010. With this additional data and results of subsequent trials, we hope to see ANA598 established as the leading non-nucleoside in HCV, suitable for combination with current standard of care as well as with other direct antivirals currently in development."

"This first Phase II data clearly demonstrates the ability of ANA598 to improve antiviral response at week 4 above what is seen with current standard of care alone," said James L. Freddo, M.D., Senior Vice President, Drug Development and Chief Medical Officer. "The RVR rate combined with a good safety and tolerability profile to date is encouraging for the prospects of ANA598 contributing to improved long-term treatment outcomes as measured by SVR."

In the ongoing Phase II study, patients are to receive ANA598 or placebo, added to SOC, for 12 weeks, after which they are to continue receiving SOC alone for 12 or 36 additional weeks. The results announced today are from a scheduled interim analysis following four weeks of dosing in the first of two planned dose cohorts. 44 patients in the first cohort (34 genotype 1a and 10 genotype 1b) received at least one dose of study medications, 29 receiving ANA598 and 15 receiving placebo. Two patients who withdrew consent during the first week of dosing for reasons unrelated to ANA598 are excluded from the analysis of antiviral response but included in the safety database. Reported antiviral response data is as of week 4. Reported safety data is as of an interim analysis date which was reached shortly after the last enrolled patient completed four weeks of dosing, and includes information through week 4 for all patients plus information subsequent to week 4 for those patients who had earlier enrollment dates.