Anadys Pharmaceuticals Commences Dosing ANA598 in Hepatitis C Patients in Phase Ib Study

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Anadys Pharmaceuticals Commences Dosing ANA598 in Hepatitis C Patients in Phase

Ib Study

Last update: 4:52 p.m. EDT Oct. 28, 2008

SAN DIEGO, Oct 28, 2008 /PRNewswire-FirstCall via COMTEX/ -- Anadys

Pharmaceuticals, Inc. (ANDS:anadys pharmaceuticals inc com

ANDS 1.99, +0.09, +4.7%) 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

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.

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

States. Due to the asymptomatic nature of HCV infection, it often goes

undetected for up to 20 years following initial infection. Each year, 8,000 to

10,000 people in the United States die from complications of HCV.

The current standard of care is a combination of pegylated interferon and

ribavirin. Inadequate response rates, in particular for patients infected with

genotype 1 HCV, along with significant side effects of approved therapy support

the medical need for improved treatment options. It is estimated that fewer than

5% of people with chronic HCV infection living in the United States are under

treatment today. Most infected individuals are unaware of their infection status

and the large majority of individuals who know their condition do not currently

receive drug therapy. There is also a growing number of individuals who have

failed interferon-based regimens who may be successfully treated with

combinations of two or more direct antivirals. It is expected that the next

generation of therapies for treatment of HCV will include small molecules, such

as ANA598, that directly act upon specific viral enzymes to inhibit viral

replication. These new therapies are expected to improve overall therapy by

increasing cure rates and potentially improving tolerability and convenience of

treatment if doses of currently used agents can be reduced or eliminated.

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.

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 (i) the expected occurrence, timing and trial design

of the planned development activities for ANA598, including Anadys' expectation

that it will have viral load data from all three cohorts of the Phase Ib study

in the first quarter of 2009; (ii) the expectation that the maximal benefit of

direct antivirals will be realized when used in combination regimens

incorporating multiple anti-HCV agents; (iii) the potential for once-daily or

twice-daily oral dosing with ANA598; (iv) predictions of future antiviral

activity of ANA598 based on plasma drug concentrations seen in the healthy

volunteer study and preclinical results to date; and (v) expectations regarding

the evolution of the market for HCV therapies. 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 and early clinical 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 competition from other biotechnology and

pharmaceutical companies, its effectiveness at managing its financial resources,

its ability to enter into collaborations around its product candidates, 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 its product

candidates 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 and Anadys' Form 10-Q for the quarter ended September 30,

2008. 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.

SOURCE Anadys Pharmaceuticals, Inc.

http://www.anadyspharma.com