Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA5

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Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study

ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

ANA598 To Be Dosed for 12 Weeks in Triple Combination SAN DIEGO, July 30

SAN DIEGO, July 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.

(Nasdaq: ANDS) today announced finalization of the protocol for the Company's

Phase II trial of ANA598 in combination with pegylated interferon-alpha and

ribavirin in hepatitis C patients. Allowance of the protocol has been received

from the United States Food and Drug Administration (FDA), and patient dosing is

expected to commence within the next several weeks.

In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo

in combination with Pegasys® (peginterferon alfa-2a) and Copegus®

(ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose

levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg

bid on day one. After week 12, patients will continue to receive SOC. Patients

who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to

stop all treatment at week 24 or 48. The primary endpoint of the study is the

proportion of patients with undetectable virus at week 12 (defined as complete

Early Virological Response, or cEVR). Additional endpoints include safety and

tolerability as well as the proportion of patients with undetectable virus at

week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24

weeks after stopping all treatment (defined as Sustained Virological Response,

or SVR).

Ninety patients are planned to be enrolled in this study - thirty patients

receiving ANA598 and fifteen receiving placebo at each dose level. The study

will be conducted at a number of clinical sites in the United States. Anadys

expects to receive 28-day safety and response (RVR) data from the 200 mg dose

level by year-end and additional on-treatment safety and response data from both

cohorts during the first two quarters of 2010.

" ANA598 has demonstrated potent antiviral activity and good tolerability as a

single agent in Phase I, as well as preclinical properties indicative of likely

synergy when used clinically in combination regimens, " said Steve Worland,

Ph.D., President and CEO of Anadys. " We are now in a position to demonstrate the

value of ANA598 when used in combination in a Phase II trial to treat hepatitis

C patients. This trial incorporates several attractive features designed to

further enhance the competitive position of ANA598, including twelve weeks of

triple combination treatment and a randomized exploration of shortening the

overall duration of HCV therapy in conjunction with ANA598 treatment. "

About ANA598

ANA598 is a non-nucleoside inhibitor of the HCV RNA polymerase. Anadys has

completed three Phase I clinical studies of ANA598 that have demonstrated potent

antiviral activity and good tolerability. In a monotherapy study in naive

genotype 1 patients, treatment with ANA598 for three days led to median declines

in viral load ranging from 2.4 to 2.9 log10 in three separate dose groups. No

patient at any dose level showed evidence of viral rebound while on ANA598, and

there were no serious adverse events.

Anadys has completed dosing in two long-term chronic toxicology studies of

ANA598 (26 weeks duration in rats and 39 weeks duration in monkeys). At the

13-week interim, the toxicology profile of ANA598 in both species was very

favorable. A preliminary assessment of the results from the 26-week study in

rats indicates a similar profile to that seen in rats at 13 weeks, in which the

only adverse finding was a marginal decrease in the rate of weight gain in

females at 1000 mg/kg, the highest dose tested. Complete results from both

studies, including 39-week data from the monkey study, are expected at the end

of the third quarter 2009.

Anadys has presented in vitro data supporting the use of ANA598 in combination

with interferon-alpha as well as with direct antivirals currently in

development. In particular, data has shown that ANA598 is synergistic in vitro

with interferon-alpha as well as representative HCV protease and polymerase

inhibitors. Furthermore, ANA598 retains full activity in vitro against mutations

conferring resistance to protease inhibitors, nucleoside polymerase inhibitors

and non-nucleoside polymerase inhibitors that act at binding sites distinct from

that of ANA598, and protease and nucleoside polymerase inhibitors retain full

activity against mutations conferring resistance to ANA598.

ANA598 has received Fast Track Status from the FDA for the treatment of chronic

hepatitis C.

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to

improving patient care by developing novel medicines for the treatment of

hepatitis C. The Company believes hepatitis C represents a large unmet medical

need in which meaningful improvements in treatment outcomes may be attainable

with the introduction of new medicines. The Company is developing ANA598, a

non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The

Company has also investigated the potential of ANA773, an oral, small-molecule

inducer of endogenous interferons that acts via the Toll-like receptor 7, or

TLR7, pathway in hepatitis C.

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) Anadys' expectation that dosing in the ANA598

Phase II study will commence in the next several weeks; (ii) the ability for

patients in the ANA598 Phase II study to achieve undetectable levels of virus at

weeks 4 and 12 and to achieve SVR; (iii) Anadys' expectation that it will

receive 28-day data from the 200 mg dose level by year end and additional data

during the first two quarters of 2010; (iv) the antiviral and tolerability

profile of ANA598 seen to date, which may not be duplicated in the Phase II

study; (v) preclinical properties indicative of likely synergy when used

clinically in combination regimens; and (vi) the belief that certain features of

the Phase II protocol have the ability to further enhance the competitive

position of ANA598. 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 or will have favorable results in the planned Phase II trial. In

addition, Anadys' results may be affected by risks related to 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 product candidates, 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, 2008 and Anadys' Current

Report on Form 8-K filed on June 4, 2009. 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.

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