Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
SAN DIEGO, April 17, 2008 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. 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."
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.
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.
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, including future clinical trials and the belief that ANA598 has the broad potential utility to be used in combination with other anti-HCV agents, regardless of class, as well as the belief that ANA598 will be an active antiviral in HCV infected patients. 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 ANA598 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 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, 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: April 2008