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The report characterized the favorable antiviral, metabolic,pharmacokinetic and preliminary toxicologic properties that supported thedecision announced in June to progress ANA598 to IND enabling studies andsubsequent clinical evaluation expected to commence in the first half of 2008.ANA598 is a potent, low-nanomolar inhibitor of HCV genotype 1a and 1breplicons and has exhibited good metabolic stability properties in in vitropreclinical studies. It also does not significantly inhibit or inducecytochrome enzymes, indicating that the compound has a low likelihood ofproducing clinical drug-drug interactions. ANA598 was well tolerated in14-day dose range finding (DRF) animal toxicology studies at all doses tested(1 to 1000mg/kg). In in vivo preclinical studies designed to be predictive ofpotential human doses, trough plasma concentrations of ANA598 24 hours postdosing exceeded the EC95 for HCV genotype 1a and 1b replicon inhibition atdoses corresponding to estimated human doses. The EC95 is the concentrationrequired to suppress hepatitis C viral RNA levels by 95% in the replicon assay.
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"We are pleased with the ANA598 plasma exposures we have observed inanimal studies at doses that were well tolerated for 14 days," said SteveWorland, Ph.D., President and Chief Executive Officer of Anadys. "In chronicviral diseases, achieving blood levels in preclinical studies that aremany-fold above concentrations needed for viral suppression is generallyrecognized as a predictor of potential clinical utility."
In June, Anadys announced the nomination of ANA598 as a clinicaldevelopment candidate. ANA598 was selected from the Company's internal NS5Bdiscovery efforts based on an optimized balance of preclinical properties andwas the result of the Company's structure-based drug design capabilities.ANA598 is undergoing IND enabling activities and an IND submission is targetedfor the first half of 2008.
"After completing the necessary IND enabling studies, we look forward toexploring the potential clinical utility of ANA598 in patients with HCV," saidJames Freddo, MD, Anadys' Chief Medical Officer. "Based on the combinedpotency, pharmacokinetic and preliminary toxicologic properties of ANA598, webelieve that this is an exciting new direct antiviral to investigate for thetreatment of patients with hepatitis C virus infection."
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company committed toadvancing patient care by developing and commercializing novel small moleculemedicines for the treatment of hepatitis C virus (HCV) infection and cancer.The Company is developing ANA598, a small-molecule, non-nucleoside inhibitorof the NS5B polymerase for the treatment of HCV and ANA773, an oral TLR7agonist prodrug for cancer.
Safe Harbor Statement
Statements in this press release that are not strictly historical innature constitute "forward-looking statements." Such statements include, butare not limited to, references to the expected timing and planned developmentactivities for ANA598, the prediction that ANA598 has a low likelihood ofproducing clinical drug-drug interactions, the use of doses in preclinicalstudies that are designed to be predictive of human doses, the belief thatachieving blood levels that are many-fold above plasma levels needed for viralsuppression is generally recognized as a predictor of potential clinicalutility, and the belief that ANA598 is an exciting new direct antiviral toinvestigate for the treatment of patients with HCV infection.. Suchforward-looking statements involve known and unknown risks, uncertainties andother factors
