Biotech Values

[DewDiligence]

ANDS Commences Patient Dosing in Phase-1 Trial of ANA773

[ANA773 is the TLR7 immmunomodulator that was the subject of the masterful quiz solution by genisi (#msg-33165423); it should not be confused with ANA598, ANDS’ other HCV drug, which is a non-nucleoside polymerase inhibitor. ANA773 is the successor to ANA975, which was discontinued in mid 2007 due to toxicity (#msg-21600252).]

http://biz.yahoo.com/prnews/081030/lath126.html

›Thursday October 30, 4:05 pm ET

SAN DIEGO, Oct. 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) announced today that it has initiated dosing ANA773 in patients chronically infected with hepatitis C virus (HCV) in Part B of a two-part protocol designed to test ANA773 in both healthy volunteers and HCV patients. ANA773 is the Company's investigational oral TLR7 agonist prodrug. In Part B of the study, patients in the first cohort will receive 800 mg of ANA773 every other day for 28 days. Doses for subsequent cohorts will be selected based on viral load and tolerability data from the 800 mg cohort.

"The initiation of patient dosing in this study of ANA773 marks the second study that Anadys has initiated in HCV patients this quarter, having commenced patient dosing earlier this week with ANA598, our non-nucleoside polymerase inhibitor," said Steve Worland, Ph.D., President and CEO of Anadys. "With two independent and potentially complementary HCV programs advancing toward viral load data, we look forward to demonstrating the breadth of our portfolio in this important therapeutic area."

ANA773 Phase I Study in HCV - Part B

In Part B of the study, patients in the first cohort will receive 800 mg of ANA773 every other day for 28 days. Doses for subsequent cohorts will be selected based on viral load and tolerability data from the 800 mg cohort. Anadys expects to have viral load data from the 800 mg cohort in the first quarter of 2009 and a complete data set in the second quarter of 2009.

About ANA773 and TLR Pharmacology

In July, Anadys announced that it was resuming clinical investigation of the TLR7 mechanism in HCV by taking ANA773 into a clinical trial under a two-part protocol designed to test ANA773 in both healthy 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.

…About Anadys

Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents: ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer.‹