Small Molecule, Toll-Like Receptor 7 Agonist, a Potential Frontline Oral
Treatment for HCV
SAN DIEGO, Feb. 2 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.
(Nasdaq: ANDS), a biopharmaceutical company committed to the discovery,
development and commercialization of novel anti-infective medicines, announced
today that it has initiated a Phase I clinical trial of ANA975 in healthy
volunteers. ANA975 is an oral prodrug of Anadys' proprietary small molecule
compound isatoribine, an agonist of Toll-Like Receptor 7 (TLR7). Results from
clinical trials of isatoribine have demonstrated a statistically significant
viral load reduction in hepatitis C patients by activating innate immunity.
"We expect that ANA975 will provide the same combination of anti-viral
effect and tolerability as observed with isatoribine, but with the added
advantage of oral administration," said Steve Worland, Ph.D., Anadys'
Executive Vice President, Research and Development. "The pharmaceutical
properties of ANA975 along with the preclinical data further support our
belief that ANA975 provides the potential to become an orally administered
frontline treatment for chronic hepatitis C virus (HCV) infection."
The Phase I clinical trial is designed to evaluate the safety,
tolerability and pharmacokinetics of ANA975 in healthy volunteers. The study
is an open-label, ascending single-dose evaluation of ANA975 to be
administered orally to a total of 18 subjects in three cohorts at 400 mg,
800 mg and 1200 mg doses. The trial is being conducted in the U.K.
ANA975 is an oral prodrug of Anadys' proprietary compound isatoribine. To
date, isatoribine has been administered to 64 subjects, including 44 patients
chronically infected with hepatitis C. Data from the Phase IB clinical trial
of isatoribine, presented at the American Association for the Study of Liver
Diseases (AASLD) 2004 Annual Meeting in Boston, provided the first reported
evidence that a selective agonist of TLR7 can reduce circulating levels of HCV
by activating innate immunity.
"We are very pleased to introduce ANA975 into the clinic ahead of
schedule," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' President and Chief
Executive Officer. "We are using our expertise in Toll-Like Receptor-based
biology and chemistry to build a strong portfolio of product candidates. We
believe that we are at the forefront of this effort and have expanded our
position around small molecules targeting Toll-Like Receptors."
Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical
company committed to advancing patient care by discovering, developing and
commercializing novel small molecule medicines for the treatment of hepatitis
C virus (HCV), hepatitis B virus (HBV) and bacterial infections. Anadys'
clinical development programs include the oral prodrug ANA975 for the
treatment of HCV and HBV, and ANA380 for the treatment of HBV. In addition,
Anadys' anti-infective therapeutic platform, including core capabilities in
Toll-Like Receptor-based small molecules and structure-based drug design, is
designed to advance a strong and continual pipeline of drug candidates into
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 the viral load reduction resulting from
administration of isatoribine to HCV infected patients and the effect on a
patient's immune system, Anadys' expectation that ANA975 will provide the same
combination of anti-viral effect and tolerability as Anadys has observed with
isatoribine in early stage clinical trials, the believed potential for ANA975
to become an orally administered frontline treatment for chronic HCV, Anadys'
efforts to utilize its expertise in Toll-Like Receptor based biology and
chemistry to build a strong portfolio of product candidates and its belief
that it is at the forefront of Toll-Like Receptor based biology and chemistry.
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. In particular, the results of initial
clinical trials are not necessarily predictive of future results, and Anadys
cannot provide any assurances that ANA975 will have favorable results in
clinical trials, or receive regulatory approval. 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 successfully develop and market products, difficulties or delays in its
clinical trials, difficulties or delays in manufacturing its clinical trials
materials, the scope and validity of patent protection for its products,
regulatory developments involving future products and its ability to obtain
additional funding to support its operations. These and other factors that
may cause actual results to differ are more fully discussed in the "Risk
Factors" section of Anadys' Form 10-Q for the quarter ended September 30,
2004. 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
SOURCE Anadys Pharmaceuticals, Inc.
CONTACT: Michael Kamdar, Sr. VP, Corporate Development and Finance,
+1-858-530-3667, firstname.lastname@example.org, or Pete De Spain, Manager, Corporate
Communications, +1-858-530-3653, email@example.com, both of Anadys
Web site: http://www.anadyspharma.com