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Anadys Pharmaceuticals, presented a late-breaker oral presentation today at the 21st International Conference on Antiviral Research (ICAR) in Montreal, Quebec, providing updated preclinical data on ANA598, a non-nucleoside inhibitor of the hepatitis C virus (HCV) NS5b polymerase
SAN DIEGO, Calif, USA | April 17, 2008 | Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) presented a late-breaker oral presentation today at the 21st International Conference on Antiviral Research (ICAR) in Montreal, Quebec, providing updated preclinical data on ANA598, a non-nucleoside inhibitor of the hepatitis C virus (HCV) NS5b polymerase.
The presentation reported several preclinical attributes of ANA598 that support the potential for beneficial combination of the product candidate with several other anti-HCV agents. Specifically, ANA598 was reported to be highly synergistic with interferon-alpha and non-antagonistic with ribavirin in cell-based assays. Furthermore, ANA598 retained full activity against a number of replicon mutations known to confer resistance to other anti-HCV agents currently in clinical development, including protease inhibitors and nucleoside polymerase inhibitors. This data confirms the broad potential utility of ANA598 to be used in combination with multiple other anti-HCV agents, regardless of class.
Anadys also presented the pharmacokinetic (PK) profile of ANA598 based on the results of 28-day toxicology studies. An oral dose of 20 mg/kg in monkeys provided plasma levels of ANA598 at 12 hours that were in excess of the protein-binding adjusted genotype 1a replicon EC95, suggesting the potential for twice-daily or once-daily dosing. In addition, ANA598 was tolerated in all preclinical studies up to the maximum doses tested.
"The preclinical PK profile combined with the previously reported potency of the agent provides further confidence that ANA598 will be an active antiviral in HCV infected patients," said James Freddo, M.D., Chief Medical Officer of Anadys. "The in vitro combination data further increases our interest in exploring the combination of ANA598 with interferon and ribavirin as well as with other experimental direct antivirals."
About ANA598
In June 2007, Anadys announced the nomination of ANA598 as a clinical development candidate. ANA598 was selected based on an optimized balance of preclinical properties, including intrinsic potency as an NS5b inhibitor, cellular activity in the hepatitis C replicon assay, oral bioavailability and early indicators of safety and tolerability. Anadys has recently completed IND enabling activities for ANA598 and pending allowance by the Food and Drug Administration, intends to initiate clinical studies of ANA598 in healthy volunteers in the second quarter of 2008. Following the healthy volunteer study, in the third quarter of 2008 Anadys plans to initiate a short-term Phase Ib study in patients infected with chronic HCV infection.
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. The Company is developing ANA598, a small-molecule, non-nucleoside inhibitor of the NS5B polymerase for the treatment of chronic hepatitis C and ANA773, an oral TLR7 agonist prodrug for cancer.
SOURCE: Anadys Pharmaceuticals, Inc. |
