Anadys Pharmaceuticals to Initiate 28-Day Clinical Trial of ANA975 in Patients With Chronic Hepatitis C
Proof-of-Concept Trial in U.S. and E.U. to Build on the Clinical Results of Previously Completed Phase I Studies 501, 502 and 503
SAN DIEGO, December 22, 2005 /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.
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