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ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients
Date:1/8/2009

-a-day), 400 mg bid or 800 mg bid. Ten patients are to be enrolled at each dose level, eight receiving active drug and two receiving placebo.

In a Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study. All reported adverse events were classified as mild or moderate, with no apparent dose relationship. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 consistent with the potential for once-daily or twice-daily oral dosing.

In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September 2008, Anadys initiated long-term, chronic toxicology studies of ANA598.

If ANA598 is successful in early stage development, the Company anticipates completion of the clinical, toxicology and manufacturing activities required to initiate Phase II studies of ANA598 in combination with current standard of care in mid-2009.

Webcast of Conference Call

Anadys will host a conference call today, January 8, 2009 at 8:30 a.m. Eastern Standard Time (5:30 a.m. Pacific Standard Time) to discuss the results from the first cohort of the ongoing Phase Ib clinical trial of ANA598. A live webcast of the call will be available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 99568266. The webcast and telephone replay will be available through January 22, 2009.

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SOURCE Anadys Pharmaceuticals, Inc.
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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. Cytokine Demonstrates Oral Efficacy of Small-Molecule MIF Inhibitors
8. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
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