ANA598 Data Presented at AASLD Highlight Positive Clinical Profile of DAA Entering Phase IIb

SAN DIEGO, Oct. 30 /PRNewswire-FirstCall/ -- 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.

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. Anadys is preparing to initiate a Phase IIb study of ANA598, the Company's direct-acting antiviral or DAA, added to current standard of care for the treatment of hepatitis C.  The Company is also preparing to resume clinical development of ANA773, the Company's oral, small-molecule inducer of endogenous interferons that acts via the Toll like receptor 7, or TLR7, pathway in hepatitis C.

Safe Harbor Statement

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to (i) the plans and trial design for the planned ANA598 Phase IIb study; (ii) the belief that the preclinical properties of ANA598 support investigation of combinations with other direct antivirals and the ability to pursue such combinations;  (iii) assessments of the potency, safety and tolerability profile of ANA598 based on the 12 week results; (iv) the durability of antiviral response after treatment with ANA598 is concluded as well as interim SVR rates based on data available to date; and (v) the beneficial effect of ANA598 in both CC and non-CC patients based on observations in the Phase II combination study. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 or ANA773 will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2009, Form 10-Q for the quarter ended September 30, 2010 and Form 8-K filed on October 15, 2010. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche Inc.

SOURCE Anadys Pharmaceuticals, Inc.