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 COMMENCES DOSING ANA773 IN
HEPATITIS C PATIENTS
SAN DIEGO, October 30, 2008 -- Anadys Pharmaceuticals, Inc. (Nasdaq:
ANDS) announced today that it has initiated dosing ANA773 in patients
chronically infected with hepatitis C virus (HCV) in Part B of a two-part
protocol designed to test ANA773 in both healthy volunteers and HCV patients.
ANA773 is the Company’s investigational oral TLR7 agonist prodrug. In Part B of the study, patients in the first cohort
will receive 800 mg of ANA773 every other day for 28 days. Doses for subsequent
cohorts will be selected based on viral load and tolerability data from the 800
mg cohort.
“The initiation of patient dosing in
this study of ANA773 marks the second study that Anadys has initiated in HCV
patients this quarter, having commenced patient dosing earlier this week with
ANA598, our non-nucleoside polymerase inhibitor,” said Steve Worland,
Ph.D., President and CEO of Anadys. “With two independent and potentially
complementary HCV programs advancing toward viral load data, we look forward to
demonstrating the breadth of our portfolio in this important therapeutic
area.”
ANA773 Phase I Study in HCV - Part B
In Part B of the study, patients in the first
cohort will receive 800 mg of ANA773 every other day for 28 days. Doses for
subsequent cohorts will be selected based on viral load and tolerability data
from the 800 mg cohort. Anadys expects to have viral load data from the 800 mg
cohort in the first quarter of 2009 and a complete data set in the second
quarter of 2009.
About ANA773 and TLR Pharmacology
In July, Anadys announced that it was
resuming clinical investigation of the TLR7 mechanism in HCV by taking ANA773
into a clinical trial under a two-part protocol designed to test ANA773 in both
healthy volunteers and patients with HCV. In October, Anadys completed dosing
in healthy volunteers. Subjects received a single dose followed by four doses
taken every other day, at levels from 200 mg to 1600 mg (with six subjects
receiving active and two receiving placebo in each dose cohort). No serious
adverse events were reported. Biomarker induction indicative of immune
activation was seen in a majority of subjects beginning at 800 mg. Some side
effects commonly seen with interferon treatment, including fever and chills,
were observed at higher doses, with the frequency and intensity of
interferon-like side effects increasing with dose. One subject at the 1200 mg
dose and two subjects at the 1600 mg dose discontinued from the trial before
completion of dosing.
ANA773 is an orally administered prodrug of a novel TLR7-specific agonist. 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 monkeys included induction of
interferon-alpha and interferon dependent responses at levels that are
sustained over 13 weeks of dosing.
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 expected occurrence, timing and trial design of the planned
development activities for ANA773,
including expectations regarding the timing for ANA773 viral load data; (ii)
the belief that the TLR7 mechanism will potentially be complementary to ANA598;
(iii) the belief that ANA773 has the potential to demonstrate benefit in
patients infected with HCV and potentially replace injectable
interferon; (iv) the belief that ANA773 can elicit immune stimulation of a
magnitude sufficient to confer therapeutic potential without adverse safety or
tolerability issues; and (v) 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 or 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.