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ANDS Begins ANA598 Dosing in Phase-1b HCV Study

[ANA598 is a non-nucleoside polymerase inhibitor, one of only two such agents in clinical trials (the other is GS9190 from GILD).]

http://biz.yahoo.com/prnews/081028/la42288.html

›Tuesday October 28, 4:52 pm ET

SAN DIEGO, Oct. 28 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) announced today that it has initiated dosing ANA598 in patients chronically infected with hepatitis C virus (HCV) in a Phase Ib study. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor. The Phase Ib clinical trial is a double-blind, placebo-controlled study that will evaluate the tolerability, pharmacokinetics and viral kinetics of multiple, ascending doses of ANA598 over a period of three days. Anadys expects to enroll approximately 30 patients in the study of ANA598 at doses of 200 mg bid (twice-a-day), 400 mg bid and 800 mg bid.

"ANA598 demonstrated favorable tolerability and pharmacokinetics as a single dose in healthy volunteers in our recently concluded Phase I study," said James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. "We look forward to building upon these results and testing the compound in HCV patients, first in this monotherapy study and subsequently in combination studies. We expect the maximal benefit of direct antivirals to be realized when used in combination regimens incorporating multiple anti-HCV agents."

ANA598 Phase Ib Study

In the Phase Ib monotherapy study, ANA598 will be administered to naive genotype 1a and 1b patients over three days, at doses of 200 mg bid, 400 mg bid or 800 mg bid. Ten patients are planned to be enrolled in each of the three cohorts - eight on active treatment and two on placebo. Anadys expects to have viral load data from all three cohorts in the first quarter of 2009. Anadys may elect to explore other dose levels of ANA598 and/or once-daily dosing based on data from the first three cohorts.

About ANA598

In September, Anadys announced preliminary results of the Phase I clinical trial of ANA598 in healthy volunteers. This trial was designed to evaluate safety and pharmacokinetics in healthy volunteers receiving single doses ranging from 400 mg to 3000 mg. ANA598 was well tolerated in this study. It was well absorbed and the human pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours, consistent with the potential for once-daily or twice-daily oral dosing. All doses achieved plasma drug concentrations predicted to display substantial antiviral activity based on preclinical results. Safety and PK data from all dose levels in the Phase I clinical trial of ANA598 will be presented in a late-breaker poster session on November 3 at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), to be held in San Francisco, California. Further preclinical data on ANA598 will be presented at AASLD in two additional poster presentations on November 4.

Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies.‹