SAN DIEGO, Dec. 22 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. announced today that it plans to initiate a Phase Ib, placebo-controlled, multiple-dose clinical trial of ANA975 in chronic hepatitis C patients in January. The trial is designed to evaluate the safety, tolerability and viral load reduction of ANA975 in hepatitis C patients. ANA975, which Anadys is developing in collaboration with Novartis, is the oral prodrug of isatoribine, a proprietary Toll-Like Receptor-7 (TLR7) agonist.
“With this study we are seeking to extend the encouraging clinical results we obtained in several Phase I clinical trials -- Studies 501, 502 and 503 -- with healthy volunteers that evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of ANA975,” said Kleanthis G. Xanthopoulos, Ph.D., Anadys’ President and CEO. “We reported the initial part of these studies at the recent annual meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2005.”
“The data from ANA975 so far demonstrate the power of our unique and proprietary oral TLR-7 prodrug technology and build on the clinical experience of the active substance, isatoribine, that has demonstrated statistically significant antiviral activity in patients chronically infected with hepatitis C virus, as we have previously reported,” said Steve Worland, Ph.D., Anadys’ Executive Vice President, Pharmaceuticals. “We are excited to see ANA975 entering the clinic in hepatitis C patients.”
ANA975 has been administered to more than 90 healthy volunteers in three completed Phase I trials (501, 502, and 503), setting the stage for the upcoming 28-day clinical study in hepatitis C infected patients. Results from several clinical trials in hepatitis C patients receiving intravenous isatoribine for one week have demonstrated statistically significant and therapeutically relevant viral load reductions. Data from the previous Phase I clinical trials of ANA975 in healthy volunteers indicate that the bioavailability of ANA975 is greater than 80 percent and conversion to isatoribine in plasma is rapid and effective, delivering levels of isatoribine that have been shown to be clinically relevant.
The trial, which will be conducted at multiple centers in the United States and the European Union, will evaluate the safety, tolerability and viral load reduction of ANA975 at multiple doses for 28 days in patients chronically infected with hepatitis C.
Patients will be assigned randomly to one of two main categories. In one category patients will receive either a predetermined dose of ANA975 once a day for 28 days or a placebo. In a second category patients will receive a predetermined dose of ANA975 twice a day for 28 days or a placebo. Anadys expects to report clinical data from this study in the first half of 2006.
Hepatitis C Virus
Hepatitis C virus causes inflammation of the liver and degradation of liver function. Approximately 80% of individuals infected with hepatitis C progress to chronic hepatitis. The most common signs and symptoms of chronic hepatitis, which may show no symptoms for many years, include an enlarged liver and spleen, jaundice, muscle wasting, excoriations (the result of scratching), ascites (swelling of the abdomen) and swelling of the ankles. Chronic infection often progresses to further, more serious complications such as cirrhosis of the liver, liver cancer and death. Of those patients who progress to chronic hepatitis, 10%-20% develop cirrhosis over a period of 20 years, with approximately 1-5% of these patients progressing to end-stage liver disease or liver cancer in their lifetime. Hepatitis C is estimated to chronically infect more than 170 million people worldwide.
The CDC reports that approximately 2.7 million Americans are chronically infected with hepatitis C and at risk of disease progression. There is no vaccine available to prevent the spread of hepatitis C.
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of hepatitis, other serious infections, and cancer. The Company has core expertise in Toll-Like Receptor-based small molecule therapeutics and structure-based drug design coupled with medicinal chemistry. Anadys’ clinical development programs include ANA975 for the treatment of hepatitis C and hepatitis B, and ANA380 for the treatment of hepatitis B. In addition, Anadys’ therapeutic platform is designed to advance a strong and continual pipeline of drug candidates into the clinic.
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 Anadys’ plan to initiate the Phase Ib trial in January, that the trial will be a proof-of-concept trial, the desire to extend the encouraging clinical results Anadys previously obtained in the previously completed Phase I clinical trials, the power of Anadys’ TLR-7 technology, the planned design of the Phase Ib clinical trial, the predictive power of the results from clinical trials of isatoribine, as well as references to the extent to which ANA975 is converted to isatoribine and the corresponding oral bioavailability of ANA975. 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 may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will have favorable results in future clinical trials or receive regulatory approval. In addition, Anadys’ results may be affected by risks related to the implementation of its collaboration with Novartis, 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 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, 2005. 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 & CorporateCommunications of Anadys Pharmaceuticals, Inc., +1-858-530-3653,vreardon@anadyspharma.com
