Anadys Pharmaceuticals Commences Dosing ANA598 in Hepatitis C Patients in Phas...(pIn September Anadys announced prelimina...),Health

Date:10/28/2008

p>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.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the United St
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SOURCE Anadys Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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