ANA773 Demonstrates Significant Antiviral Response in Early Clinical Trial in Hepatitis C Patients
Proof of Concept Achieved for Second Anadys HCV Product Candidate
SAN 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."
James 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 Pharmacology
ANA773 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 Anadys
Anadys 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.
CONTACT: Investors, Amy Conrad, Anadys Pharmaceuticals,
Inc.,
aconrad@anadyspharma.com,
+1-858-530-3607, or Media, Ian Stone,
ian.stone@russopartnersllc.com,
or David Schull,
david.schull@russopartnersllc.com,
both of Russo Partners, LLC,
+1-619-528-2220
Web Site: http://www.anadyspharma.com
Posted: August 2009
