ANA598 Demonstrates SVR12 in 100% of First Group of HCV Patients Randomized to Stop All Treatment at Week 24
Benefit of ANA598 Post Therapy with IFN/RBV Persists in 6 of 6 Patients Company to Review Data During Q2 Financial Results Call at 8:30 AM EDT Today
SAN DIEGO, July 29 /PRNewswire-FirstCall/ -- Anadys
Pharmaceuticals, Inc. (NASDAQ:ANDS) today 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>
Conference Call Webcast and Slides
Anadys will hold a conference call and webcast today, Thursday,
July 29, 2010 at 8:30 a.m. Eastern Daylight Time to discuss the
post-treatment results from the ongoing Phase II combination study
and Anadys' second quarter 2010 financial results A live webcast of
the call, including accompanying slides, will be available online
at www.anadyspharma.com. A telephone replay with slides will also
be available approximately one hour after completion of the call.
To access the telephone replay, dial 888-286-8010 (domestic) or
617-801-6888 (international), passcode 28631163. The webcast and
telephone replay will be available through August 12, 2010.
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.
CONTACT: Investors, Amy Conrad of Anadys Pharmaceuticals,
Inc.,
+1-858-530-3607, aconrad@anadyspharma.com; or
Media, Ian Stone,
ian.stone@russopartnersllc.com,
or David Schull,
david.schull@russopartnersllc.com,
both of Russo Partners, LLC,
+1-619-528-2220, for Anadys Pharmaceuticals, Inc.
Web Site: http://www.anadyspharma.com/
Posted: July 2010
