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 VirusesANA598 demonstrates favorable preclinical antiviral, metabolic, pharmacokinetic and preliminary toxicologic properties
SAN DIEGO, September 11, 2007 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. presented preclinical data today on ANA598, a non-nucleoside inhibitor of the HCV NS5B polymerase, during a poster session at the 14th International Symposium on Hepatitis C Virus and Related Viruses.
The report characterized the favorable antiviral, metabolic, pharmacokinetic and preliminary toxicologic properties that supported the decision announced in June to progress ANA598 to IND enabling studies and subsequent clinical evaluation expected to commence in the first half of 2008. ANA598 is a potent, low-nanomolar inhibitor of HCV genotype 1a and 1b replicons and has exhibited good metabolic stability properties in in vitro preclinical studies. It also does not significantly inhibit or induce cytochrome enzymes, indicating that the compound has a low likelihood of producing clinical drug-drug interactions. ANA598 was well tolerated in 14-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 of potential human doses, trough plasma concentrations of ANA598 24 hours post dosing exceeded the EC95 for HCV genotype 1a and 1b replicon inhibition at doses corresponding to estimated human doses. The EC95 is the concentration required to suppress hepatitis C viral RNA levels by 95% in the replicon assay.
"We are pleased with the ANA598 plasma exposures we have observed in animal studies at doses that were well tolerated for 14 days," said Steve Worland, Ph.D., President and Chief Executive Officer of Anadys. "In chronic viral diseases, achieving blood levels in preclinical studies that are many-fold above concentrations needed for viral suppression is generally recognized as a predictor of potential clinical utility."
In June, Anadys announced the nomination of ANA598 as a clinical development candidate. ANA598 was selected from the Company's internal NS5B discovery efforts based on an optimized balance of preclinical properties and was the result of the Company's structure-based drug design capabilities. ANA598 is undergoing IND enabling activities and an IND submission is targeted for the first half of 2008.
"After completing the necessary IND enabling studies, we look forward to exploring the potential clinical utility of ANA598 in patients with HCV," said James Freddo, MD, Anadys' Chief Medical Officer. "Based on the combined potency, pharmacokinetic and preliminary toxicologic properties of ANA598, we believe that this is an exciting new direct antiviral to investigate for the treatment of patients with hepatitis C virus infection."
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company committed to advancing patient care by developing and commercializing novel small molecule medicines for the treatment of hepatitis C virus (HCV) infection and cancer. The Company is developing ANA598, a small-molecule, non-nucleoside inhibitor of the NS5B polymerase for the treatment of HCV and ANA773, an oral TLR7 agonist prodrug for cancer.
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 the expected timing and planned development activities for ANA598, the prediction that ANA598 has a low likelihood of producing clinical drug-drug interactions, the use of doses in preclinical studies that are designed to be predictive of human doses, the belief that achieving blood levels that are many-fold above plasma levels needed for viral suppression is generally recognized as a predictor of potential clinical utility, and the belief that ANA598 is an exciting new direct antiviral to investigate for the treatment of patients with HCV infection.. 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 studies may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates 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 risks related to its agreements with Novartis and LG Life Sciences, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, 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 involving future products 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, 2006 and Anadys' Form 10-Q for the quarter ended June 30, 2007. 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.
Posted: September 2007