Anadys presents data of ANA598 for hepatitis C treatment at AASLD Annual Meeting

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced the ANA598 data to be presented at the 61st Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston, MA.  ANA598, the Company's direct-acting antiviral (DAA) being developed for the treatment of hepatitis C, will be discussed in two presentations at the conference:  

• On Sunday, October 31, 2010 at 3:00 pm Eastern Daylight Time, Eric Lawitz, M.D., a principal investigator of the study, will give an oral presentation titled, "Safety and Antiviral Activity of ANA598 in Combination with Pegylated Interferon alpha 2A Plus Ribavirin in Treatment-Naive Genotype-1 Chronic HCV Patients."  The slides will be available on the Company's website at www.anadyspharma.com following conclusion of the presentation.  
• On Tuesday, November 2, 2010 at 7:00 am Eastern Daylight Time, Anadys will present data in a poster titled, "IL28B Polymorphism and Kinetics of Antiviral Activity for ANA598 in Combination with Pegylated Interferon alpha 2A Plus Ribavirin in Treatment-Naive Genotype-1 Chronic HCV Patients."  The poster will be available on the Company's website at www.anadyspharma.com.  

"We are pleased with the positive clinical profile seen to date for ANA598, as well as its preclinical properties that support investigation of combinations with other direct antivirals," said James L. Freddo, M.D., Senior Vice President, Drug Development and Chief Medical Officer of Anadys.  "In the upcoming Phase IIb study, we look forward to testing ANA598 for the first time in treatment-experienced patients, as well as in a larger population of treatment-naive patients."

In the oral presentation, data from an ongoing Phase II combination study show that ANA598 added to pegylated interferon and ribavirin (current standard of care, or SOC) accelerated the rate of patients achieving undetectable levels of virus compared to placebo plus SOC, and that the antiviral response was equivalent at 200 mg bid and 400 mg bid ANA598.  The data from the study further show a durable antiviral response through 12 weeks, with only a single patient (<2% of patients in the ANA598 arms) experiencing viral breakthrough while receiving ANA598 plus SOC.  The safety profile of ANA598 through 12 weeks was excellent in the study, with reported adverse events being typical for patients treated with interferon and ribavirin alone, and the incidence of rash in patients receiving ANA598 200 mg bid plus SOC in the study was comparable to the group receiving placebo plus SOC.  

Additional data from the Phase II combination study will be presented reflecting the persistence of ANA598's benefit beyond week 12. 39 of 41 patients (>95%) who achieved undetectable levels of virus at week 12 in the two active arms have maintained undetectable levels while continuing to receive SOC through the latest available measurements.  For patients who, per protocol, concluded all treatment at week 24, interim analysis of SVR data for available patients indicates that 8 of 11 patients maintained undetectable levels of virus 12 weeks later, referred to as a Sustained Virological Response 12, or SVR12. The three patients who relapsed after concluding treatment at week 24 demonstrated the lowest week 4 ribavirin levels of all patients who concluded treatment at week 24, consistent with the known impact of ribavirin levels on converting on-treatment response to SVR.  Data is available for three patients 24 weeks after concluding treatment.  All three patients achieved an SVR24, recognized as a viral cure.

In the poster presentation on Tuesday, November 2, 2010, Anadys will present additional data from the Phase II combination study showing that the addition of ANA598 to SOC conferred benefit independent of a patient's IL-28B genotype. In patients with the IL-28B genotype most responsive to SOC (referred to as CC), ANA598 accelerated the rate of achieving undetectable levels of virus, with 82% of patients who received ANA598 plus SOC achieving undetectable levels by week 4, compared to 27% of patients who received placebo plus SOC.  In patients with IL-28B genotypes less responsive to SOC (referred to as CT and TT, or collectively non-CC), ANA598 both accelerated the rate of achieving undetectable levels of virus and increased the percentage of patients with undetectable levels of virus at week 12.  In the non-CC patients, 38% of patients who received ANA598 plus SOC achieved undetectable levels of virus by week 4, compared to 8% of patients who received placebo plus SOC, and 73% of patients who received ANA598 plus SOC achieved undetectable levels of virus at week 12, compared to 47% of patients who received placebo plus SOC.  

Phase II Combination Study

In the ongoing Phase II study, approximately 90 treatment-naive genotype 1 HCV patients have received ANA598 or placebo in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) for 12 weeks at dose levels of 200 mg twice-daily (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 achieved undetectable levels of virus at weeks 4 and 12 were 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 are being 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) and is being conducted at a number of clinical sites in the United States.

SOURCE Anadys Pharmaceuticals, Inc.