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Anadys Pharmaceuticals Commences Dosing ANA773 in Hepatitis C Patients
Date:10/30/2008

thy volunteers and patients with HCV. In October, Anadys completed dosing in healthy volunteers. Subjects received a single dose followed by four doses taken every other day, at levels from 200 mg to 1600 mg (with six subjects receiving active and two receiving placebo in each dose cohort). No serious adverse events were reported. Biomarker induction indicative of immune activation was seen in a majority of subjects beginning at 800 mg. Some side effects commonly seen with interferon treatment, including fever and chills, were observed at higher doses, with the frequency and intensity of interferon-like side effects increasing with dose. One subject at the 1200 mg dose and two subjects at the 1600 mg dose discontinued from the trial before completion of dosing.

ANA773 is an orally administered prodrug of a novel TLR7-specific agonist. Results from preclinical pharmacology studies have shown that ANA773 can elicit desired immune responses and that the profile of response can be modulated by both dose and schedule of administration. Results of completed 13-week GLP toxicology studies have shown that with every-other-day dosing of ANA773, immune stimulation of a magnitude believed to confer therapeutic potential can be achieved without adverse toxicology findings. The immune stimulation observed with every-other-day dosing of ANA773 in monkeys included induction of interferon-alpha and interferon dependent responses at levels that are sustained over 13 weeks of dosing.

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
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SOURCE Anadys Pharmaceuticals, Inc.
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