Investor Contact: Media
Contact:
James T. Glover Ian Stone
or David Schull
SVP, Operations & CFO Russo Partners, LLC
Anadys Pharmaceuticals, Inc. (619) 814-3510
(858) 530-3763 ian.stone@russopartnersllc.com
jglover@anadyspharma.com david.schull@russopartnersllc.com
ANADYS PHARMACEUTICALS ANNOUNCES SINGLE DOSE SAFETY
AND PHARMACOKINETICS RESULTS FOR ANA598 IN HEALTHY VOLUNTEERS
Phase I Clinical Data and Additional Preclinical
Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD
ANA598 Phase I Study Results
In the Phase I study in healthy volunteers,
ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg,
1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort
received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all
doses and there were no serious adverse events or withdrawals from the study,
although definitive conclusions regarding product safety and tolerability
cannot be made until the results of future clinical trials of longer duration
in more patients are known. All reported adverse events were classified as mild
or moderate, with no apparent dose relationship and no pattern of events within
any body system. The pharmacokinetic profile demonstrated sustained plasma
levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22
hours in the fed state, consistent with the potential for once-daily or
twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours
apart, the concentration of ANA598 in plasma 12 hours after the second dose was
83 μg/mL, which substantially exceeds the level
predicted to display antiviral potency.
The data will be presented in a late-breaker
poster titled “Results of a Phase I Safety, Tolerability and
Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in
Healthy Volunteers”, at 1:00 p.m. PST on Monday, November 3.
ANA598 Preclinical Data at AASLD Meeting
In addition to the results of the Phase I
healthy volunteer study, Anadys is presenting
additional data on the preclinical profile of ANA598 at the AASLD Meeting on
Tuesday, November 4.
•
In a poster titled “In Vitro Studies Demonstrate that Combinations
of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the
Potential to Overcome Viral Resistance”, Anadys will present the results
of in vitro studies that show ANA598 to be synergistic with
interferon-alpha, the protease inhibitor telaprevir (VX-950), and the
nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These
studies also show that ANA598 retains activity against mutants known to confer
resistance to other classes of direct antivirals, including protease inhibitors,
nucleoside inhibitors and non-nucleosides that bind at the thumb site.
Genotypic mutations resistant to ANA598 will be shown to be fully susceptible
to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be
presented demonstrating synergy between ANA598 and cytokines induced by ANA773,
Anadys’ TLR7 agonist oral prodrug, also in development for hepatitis C.
These data strongly support the potential for ANA598 to be used in combination
with multiple other agents approved or under investigation for hepatitis C.
•
In a poster titled “Antiviral Efficacy of the HCV RNA Polymerase
Inhibitor ANA598 in the Chimpanzee Model of HCV Infection”, Anadys will
present data showing that ANA598 exhibits a substantial antiviral effect
against both genotype 1a and 1b. In two HCV genotype
1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6
log10 were observed within 24 to 48 hours after the initial dose. In one animal
the viral load reduction was sustained throughout the remaining dosing period,
while in the second animal a modest rise in viral load was seen over days three
and four. In two HCV genotype 1a animals that each
received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10
were seen at 48 hours post-dose.
About ANA598
Anadys recently initiated patient dosing in a
Phase Ib study of ANA598 in HCV patients. Naïve genotype 1a and 1b
patients will receive ANA598 over three days at doses of 200 mg bid
(twice-a-day), 400 mg bid or 800 mg bid. Ten patients will be enrolled at each
dose level, eight receiving active drug and two receiving placebo. Anadys
recently completed dosing in the Phase I study of ANA598 in healthy volunteers.
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
Clinical Need and Market
Chronic HCV infection is a serious public
health concern affecting approximately 3.2 million people in the
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
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.
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 belief that ANA598 is one of the leading non-nucleoside polymerase
inhibitors currently in development for the treatment of HCV; (ii) the
potential for ANA598 to be used in combination with multiple other agents
approved or under investigation for hepatitis C; (iii) the potential for
once-daily or twice-daily oral dosing of ANA598; (iv) the level of plasma drug
concentration of ANA598 predicted to display antiviral potency; (v) the ability
of Anadys to transition into Phase II studies of ANA598 during 2009; and (vi)
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 and ANA773 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
risks related to competition from other biotechnology and pharmaceutical
companies, its effectiveness at managing its financial resources, 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.