ANA598 Demonstrates SVR12 In 100% Of First Group Of HCV Patients Randomized To Stop All Treatment At Week 24

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ANA598 Demonstrates SVR12 In 100% Of First Group Of HCV Patients Randomized To

Stop All Treatment At Week 24

Main Category: Liver Disease / Hepatitis

Also Included In: Clinical Trials / Drug Trials; Pharma Industry / Biotech

Industry

Article Date: 30 Jul 2010 - 1:00 PDT

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced that six of six patients

(100%) in the ANA598 200 mg twice daily (bid) arm who were randomized to stop

all treatment at Week 24 in an ongoing Phase II trial maintained undetectable

levels of virus 12 weeks after stopping treatment, referred to as Sustained

Virological Response 12, or SVR12.

The Company also reported that all available patients from the ANA598 200 mg arm

who were previously reported to have undetectable levels of virus at Week 24 and

continued on pegylated interferon and ribavirin (current standard of care, or

SOC) also maintained undetectable levels of virus at Week 36. In addition, all

patients from the ANA598 400 mg arm who were previously reported to have

undetectable levels of virus at Week 12 and continued on SOC maintained

undetectable levels of virus at Week 24. ANA598, Anadys' direct-acting antiviral

or DAA, is being developed to treat hepatitis C and is in an ongoing Phase II

trial in combination with pegylated interferon and ribavirin.

" The SVR12 data reported today for ANA598 are highly encouraging, " said Steve

Worland, Ph.D., President and CEO of Anadys. " These data illustrate the

potential for HCV patients to be successfully treated with shortened courses of

treatment, reflecting the continuing benefit of ANA598 post-therapy. We believe

these data, coupled with the excellent barrier to resistance demonstrated in

this trial as well as the favorable safety and tolerability, confirm ANA598's

position as one of the most attractive agents in Phase II HCV development

today. "

The six patients who stopped all treatment at Week 24 were part of an

investigation of response-guided treatment duration for ANA598 in which patients

who had achieved undetectable levels of virus (<15 IU/mL) at Weeks 4 and 12 were

randomized 1:1 to stop all treatment at Week 24 or Week 48. In addition to the

six patients who stopped treatment at Week 24, six patients in the 200 mg bid

arm are continuing to receive SOC alone through Week 48 for comparison purposes.

Additionally, 14 patients from the ANA598 400 mg bid arm and 4 patients from the

control arm (receiving placebo plus SOC) met the stopping criteria and have been

randomized to stop all treatment at Week 24 or 48. The initial post-treatment

results from these latter arms are expected later this year for those patients

who stopped therapy at Week 24.

Phase II Combination Study

In the ongoing Phase II study, approximately 90 treatment-naive genotype 1 HCV

patients have received ANA598 or placebo in combination with Pegasys®

(peginterferon alfa-2a) and Copegus® (ribavirin, USP) for 12 weeks at dose

levels of 200 mg bid or 400 mg bid, each with a loading dose of 800 mg bid on

day one. After week 12, patients are to continue receiving SOC. Patients who

achieved undetectable levels of virus at weeks 4 and 12 were randomized to stop

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

proportion of patients who achieve undetectable levels of 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 levels of virus at week 4 (defined as Rapid Virological Response,

or RVR). Patients will be followed for 24 weeks after stopping therapy to

determine the rate of Sustained Virological Response, or SVR. Approximately 90

patients have been enrolled in this study with approximately 30 patients

receiving ANA598 plus SOC at each dose level and 30 patients receiving placebo

plus SOC. The study is being managed by the Duke Clinical Research Institute

(DCRI) and is being conducted at a number of clinical sites in the United

States.

About ANA598

ANA598, a direct-acting antiviral or DAA, is a non-nucleoside inhibitor of the

HCV RNA polymerase and is wholly owned by Anadys. In an ongoing Phase II study

in which HCV patients received ANA598 at 200 mg bid or 400 mg bid in combination

with interferon and ribavirin for twelve weeks, both dose levels showed

comparable cEVR rates of 73-75% and a favorable safety profile. In a previous

Phase I study, ANA598 demonstrated potent antiviral activity, including median

end-of-treatment declines in viral load ranging from 2.4 to 2.9 log10 in a three

day monotherapy study in treatment-naïve genotype 1 patients. ANA598 has also

demonstrated a very favorable resistance profile.

Anadys has completed two long-term chronic toxicology studies of ANA598 (26

weeks duration in rats and 39 weeks duration in monkeys). The No Observed

Adverse Effect Level, or NOAEL, is 1000 mg/kg, the highest dose tested, in both

the rat and monkey. The completed toxicology studies support the ongoing Phase

II clinical study as well as future clinical studies of longer duration.

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

with interferon-alpha as well as with other anti-HCV agents currently in

development that act through diverse mechanisms. In particular, data has shown

that ANA598 is synergistic in vitro with interferon-alpha as well as

representative HCV protease inhibitors, polymerase inhibitors, NS5A inhibitors

and cyclophilin inhibitors. In vitro combination treatment at clinically

relevant concentrations of ANA598 with interferon-alpha as well as DAAs from

multiple classes results in clearance of HCV RNA from cells rather than

selection of resistant isolates. 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, while protease and nucleoside

polymerase inhibitors retain full activity in vitro against mutations conferring

resistance to ANA598.

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

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) ANA598's initial SVR12 profile based on the

results from the six patients in this first group; (ii) the potential for HCV

patients to be successfully treated with shortened courses of treatment,

reflecting the continuing benefit of ANA598 post-therapy; (iii) the belief that

ANA598 is one of the most attractive agents in Phase II HCV development today;

(iv) the expected timing for post-treatment results from the other dose groups;

and (v) the ability for patients to achieve an SVR in the Phase II combination

study. 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 continue to have favorable results as the Phase II trial

progresses. 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 transactions 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 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, 2009, Form

10-Q for the quarter ended March 31, 2010 and Form 8-K filed on May 26, 2010.

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.

Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche Inc.

Source: Anadys Pharmaceuticals, Inc