ANA773 HCV Toll-Receptor Reduced Viral Load, oral inducer of endogenous interfer

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ANA773 HCV Toll-Receptor Reduced Viral Load, oral inducer of endogenous

interferons that acts via the toll like receptor 7 (TLR7) pathway, 10-day

monotherapy study

Proof of Concept Achieved for Second Anadys HCV Product Candidate SAN DIEGO,

Aug. 11SAN DIEGO, Aug. 11 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.

(Nasdaq: ANDS) today announced viral load data for the final cohort of hepatitis

C patients in a Phase I clinical trial of ANA773, the Company's oral inducer of

endogenous interferons that acts via the toll-like receptor 7 (TLR7) pathway. In

patients who received 2000 mg ANA773 every other day over 10 days, the mean

(+/-SEM) maximal decline in viral load was 1.3 (+/-0.4) log10, compared to a

mean maximal decline of 0.3 (+/-0.1) log10 in patients who received placebo

(p=0.037). Five of the eight patients who received 2000 mg ANA773 experienced a

maximal decline of greater than 1 log, while none of the eight patients who

received placebo experienced a decline of greater than 1 log (p<0.001 for the

proportion of patients with maximal response greater than 1 log compared to

placebo). The mean end-of-treatment decline was 0.6 log10 in patients who

received 2000 mg ANA773 compared to 0.1 log10 in patients who received placebo.

ANA773 was well-tolerated in patients throughout the course of the study and

there were no serious adverse events reported. " ANA773 has demonstrated a

significant short-term antiviral response in HCV patients, comparable to many

historical reports of interferon as a single agent, " commented Steve Worland,

Ph.D., Anadys' President and CEO. " Given its oral delivery and favorable

tolerability profile to date, we believe that ANA773 holds promise as a

potential replacement for injectable interferon products in HCV therapy. We

intend to seek partnership opportunities to continue advancing the development

of ANA773, with the objective of creating well-tolerated, all oral combination

regimens to treat hepatitis C. " L. Freddo, M.D., Anadys' Senior Vice

President, Drug Development and Chief Medical Officer added, " We are very

encouraged by this data and the potential to further improve response by

combining ANA773 with other agents, including ribavirin, an agent that improves

response to interferon. Additionally, alternative dosing schedules may further

improve pharmacological response to TLR7 activation, as was seen in preclinical

studies of ANA773. " In an earlier cohort in which six patients received 1600 mg

ANA773 every other day over 28 days, the mean (+/-SEM) maximal decline was 1.0

(+/-0.3) log10 (p>0.1 compared to placebo), with two patients experiencing a

maximal decline of greater than 1 log during treatment. The mean

end-of-treatment decline was 0.5 log10 at 1600 mg. Patients who received lower

doses than 1600 mg showed correspondingly less antiviral response. The Company

intends to present complete results from this study at the upcoming Annual

Meeting of the American Association for the Study of Liver Diseases (AASLD),

Oct. 30 - Nov. 3 in Boston. ANA773 Phase I Clinical Trial in HCV The Phase I

clinical trial of ANA773 in HCV was conducted in the Netherlands under a

two-part protocol. Part A of the study included both single and multiple doses

of ANA773 in healthy volunteers. Successive cohorts of volunteers received

ascending dose levels of ANA773. The primary objectives of Part A of the study

were to assess safety and tolerability. Full results from Part A of the study

were presented at the EASL Conference in April of this year. In Part B of the

study, HCV patients received ANA773 every other day for either 28 or 10 days.

The primary objectives of Part B were to assess safety, tolerability and viral

load decline. Doses initially explored in Part B of the study were 800 mg, 1200

mg, and 1600 mg dosed every other day for a period of 28 days. Based on the

viral load data from the 1600 mg cohort, in April of this year Anadys amended

the protocol to include a fourth cohort of HCV patients who received 2000 mg of

ANA773 dosed every other day over a period of 10 days. About ANA773 and TLR

PharmacologyANA773 is the Company's oral inducer of endogenous interferons that

acts via the toll like receptor 7 (TLR7) pathway. 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 preclinical studies included induction of interferon-alpha and

interferon dependent responses at levels that are sustained over 13 weeks of

dosing. Furthermore, dose-dependent stimulation of innate immune response in

healthy volunteers was observed in Part A of the Phase I clinical trial with

ANA773 (presented at EASL, 2009).About AnadysAnadys 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' belief that ANA773 holds promise as a

potential replacement for injectable interferon products in HCV therapy; (ii)

Anadys' ability to seek and obtain partnership opportunities to further the

development of ANA773; (iii) the ability to create well-tolerated, all oral

combination regimens to treat hepatitis C; (iv) the potential to further improve

response by combining ANA773 with other agents, including ribavirin; and (v) the

potential for alternative dosing schedules to further improve pharmacological

response to TLR7 activation. 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 ANA773 will not

have unforeseen safety issues or will have favorable results in future clinical

studies. Furthermore, Anadys cannot provide any assurances that it will be able

to obtain a partnership around ANA773 or that the development of the program

will be continued. 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

its Form 10-Q for the quarter ended June 30, 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.SOURCE Anadys

Pharmaceuticals, Inc.