SAN DIEGO, May 2 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. described its optimization of a series of non-nucleoside compounds that potently inhibit the HCV NS5b polymerase enzyme during a podium presentation at the 20th International Conference on Antiviral Research (ICAR) in Palm Springs, CA today at 3:30 p.m. PDT (6:30 p.m. EDT).
Anadys reported optimizing NS5b polymerase inhibitors with nanomolar potency in both biochemical and replicon assays and with promising metabolic properties.
“Our work in our AN 025-1 program has led to several proprietary, non- nucleoside compounds with excellent potency against the NS5b polymerase, a key enzyme necessary for the production of new HCV RNA in infected cells,” said Lawrence C. Fritz, Ph.D., president and chief executive officer of Anadys Pharmaceuticals. “We are especially excited about the progress we have made in recent months in this HCV direct antiviral program and look forward to nominating a candidate this year from the ANA59X sub-series for clinical development as an orally-administered drug.”
Background
HCV is a leading cause of chronic liver disease. Current therapies for genotype 1 HCV, the most common form of HCV, are associated with sub-optimal response rates and debilitating side effects. There remains an urgent need for the development of more effective and well-tolerated HCV treatments.
Methods
Anadys’ researchers sought to discover small-molecule, non-nucleoside inhibitors of the HCV genotype 1 polymerase. The use of structure-based drug design methods facilitated investigation of a series of chemical classes. Systematic exploration of variations of the structures of the compounds resulted in a number of compounds that inhibit the NS5b enzyme with low nanomolar potencies. Knowledge of the parameters that provide potency facilitated work to explore other parameters, such as metabolic stability in vitro and pharmacokinetic behavior in animals.
“Our researchers have had considerable success in using structural data to guide our medicinal chemistry,” said Devron R. Averett, Ph.D., chief scientific officer of Anadys. “Anadys’ knowledge in this area has led us to attractive compounds that combine improved inhibitory potency against the genotype 1 NS5b enzyme with promising metabolic characteristics.”
AN 025-1 Series
In 2007, Anadys expects to nominate a new preclinical candidate from the ANA59X sub-series of Anadys’ AN025-1 program, a series of non-nucleoside NS5B polymerase inhibitors, for the treatment of chronic HCV infection. Non- nucleoside polymerase inhibitors are an example of direct antivirals. Direct antivirals act against the hepatitis C virus itself in contrast to immunomodulators which activate the body’s immune system to attack the virus. The NS5b polymerase is a virally encoded enzyme essential to replication of HCV in the body. Anadys has identified a specific site on this enzyme that we believe is preferred as a drug target. Within the AN 025-1 program the Company has identified non-nucleoside compounds that bind to this specific location. These compounds directly inhibit replication of HCV in laboratory experiments at concentrations that Anadys believes will be achievable in humans. Anadys has optimized multiple characteristics of these compounds in order to identify a pre-clinical candidate to develop as an orally administered drug.
Hepatitis C Virus
There is currently no vaccine available to prevent the spread of HCV. The World Health Organization (WHO) reports that an estimated 170 million persons are chronically infected globally with HCV and 3 to 4 million persons are newly infected each year. Cirrhosis develops in about 10-to-20 percent of persons with chronic infection, and liver cancer develops in 1-to-5 percent of persons with chronic infection over a period of 20-to-30 years. Most patients suffering from liver cancer who do not have hepatitis B virus infection have evidence of HCV infection. The mechanisms by which HCV infection leads to liver cancer are still unclear. In the US, the National Institutes of Health estimate that HCV results in 10,000 to 12,000 deaths annually. The Center for Disease Control and Prevention estimated that the number of deaths could increase to nearly 40,000 by 2010. Hepatitis C also exacerbates the severity of underlying liver disease when it coexists with other hepatic conditions.
According to industry analyst reports and available market data, 3.2 million people are infected with HCV in the United States with only about 100,000 patients in the U.S. receiving treatment annually. Even so, it is estimated that annual U.S. sales of HCV treatments are approximately $3.5 billion. The total U.S. sales of HCV therapies are expected to continue to grow significantly as better therapies that provide greater efficacy and better tolerability become available.
About Anadys
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 viral diseases and cancer. The Company’s programs focus on Toll-Like Receptor-based small molecule product candidates and direct antiviral compounds that inhibit key steps in viral proliferation. The Company has core expertise in medicinal chemistry coupled with structure-based drug design, and is developing compounds for the treatment of hepatitis C infection, hepatitis B infection and cancer.
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 the expected timing and plans for nominating a compound from the ANA59X sub-series, the believed potency and metabolic characteristics of compounds in Anadys’ AN 025-1 program and references to the expected market growth and commercial opportunities 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. In particular, the results of in vitro studies and initial clinical trials may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates 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 its collaborative relationships with Novartis and LG Life Sciences, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, the level of effort that its collaborative partners devote to development and commercialization of its product candidates, difficulties or delays in its pre-clinical 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 future products 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, 2006. 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.
Anadys Pharmaceuticals, Inc.
CONTACT: Vince Reardon, Sr. Director, Investor Relations, InvestorRelations & Corporate Communications, of Anadys Pharmaceuticals, Inc.,+1-858-530-3653, vreardon@anadyspharma.com
Web site: http://www.anadyspharma.com/
