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ANA598 Demonstrates Positive 4-Week Results at 200 mg BID
Date:12/17/2009

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.


    Preliminary Antiviral Response Assessment

                         total             genotype 1a        genotype 1b
                        patients            patients            patients
                    ANA598    Placebo   ANA598    Placebo   ANA598   Placebo
                     +SOC      +SOC      +SOC      +SOC      +SOC     +SOC
                    ---------------------------------------------------------
    RVR
    ---
    Percentage
     of Patients
     with
     Undetectable     56%        20%      50%        17%       71%       33%
     HCV RNA        (15/27)    (3/15)   (10/20)    (2/12)     (5/7)     (1/3)
     (<15 IU/ml)
     at Week 4

    VIRAL LOAD
     CHANGE
    ----------
    Mean Decline
     in HCV
     RNA (log10
     IU/ml) at
     Week 4            4.1       2.7       4.2       2.4     
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SOURCE Anadys Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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Related medicine technology :

1. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
2. Anadys Pharmaceuticals Announces Positive Results for ANA598 in Animal Model of Chronic Hepatitis C Virus Infection
3. Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
4. Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA598
5. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
6. Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers
7. ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients
8. ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients
9. Anadys Pharmaceuticals Commences Dosing in Phase II Study of ANA598
10. Cytokine Demonstrates Oral Efficacy of Small-Molecule MIF Inhibitors
11. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
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