Biotech Values

[DewDiligence]

ANDS Initiates Phase-1 Trial of ANA598,
a Non-Nuke Polymerase Inhibitor for HCV

[ANDS’ initial attempt in HCV, a nucleoside prodrug called ANA75, was discontinued in mid 2007 due to animal toxicity (#msg-21600252).]

http://biz.yahoo.com/prnews/080602/lam076.html

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Monday June 2, 4:05 pm ET

SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) announced today the initiation of dosing in a Phase I clinical trial of ANA598, an investigational oral non-nucleoside polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The objectives of this trial are to assess safety, tolerability, and pharmacokinetics following ascending single oral doses of ANA598 in healthy volunteers. Approximately 40 healthy subjects will participate in the study, which is being conducted in the United States. Following successful completion of the healthy volunteer study, Anadys plans to begin a Phase Ib study of ANA598 in HCV-infected patients in the third quarter of 2008.

"Based on its very favorable preclinical profile, including potency, pharmacokinetics, and tolerability, we believe ANA598 has the potential to become an important component of future combination therapy for patients with HCV infection," said James Freddo, M.D., Anadys' Chief Medical Officer. "We are excited about initiating this clinical program and look forward to future trials of ANA598 in HCV patients, first as a single agent and then in subsequent combination studies. We expect the full benefit of direct antivirals to be demonstrated when studied as components of novel combination regimens incorporating multiple anti-HCV agents."

Steve Worland, Ph.D., Anadys' President and CEO commented, "This is a significant milestone for Anadys. ANA598 is the second internally discovered compound that we've moved into clinical studies this year. With the commencement of dosing in a Phase I clinical trial for ANA773 in cancer patients in February and this study of ANA598 underway, Anadys is now focused on achieving important clinical milestones in both programs."

About ANA598

ANA598 is a highly potent and selective inhibitor of HCV genotypes 1a and 1b NS5b RNA polymerases (IC50<1 nM) and of HCV replication in cell culture (EC50 values for genotypes 1b and 1a replicons are 3 and 50 nM, respectively). ANA598 has been well-tolerated in all preclinical studies, including 28-day GLP toxicology studies, and was selected as a development candidate in June 2007.
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