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Clinical Study of ANA971 Initiated, Orally Administered Prodrug of Isatoribine

SAN DIEGO--(BUSINESS WIRE)--Feb. 19, 2004-- Anadys Pharmaceuticals, Inc. ("Anadys") announced today that it has initiated a clinical trial of ANA971, an orally administered prodrug of isatoribine. Isatoribine is a nucleoside analog in development for the treatment of chronic hepatitis C virus (HCV) infection. To date, isatoribine has been administered to 48 subjects, including 28 patients chronically infected with HCV. A recent clinical study showed that intravenous administration of isatoribine was well tolerated and safe at all doses tested. Interim results from that study have also shown preliminary biological activity and viral load reduction in the patient populations whose clinical data has been completed and analyzed. ANA971, which was discovered by Anadys, is a prodrug designed to improve the oral bioavailability of isatoribine. Anadys has exclusive rights to market and commercialize isatoribine and ANA971 worldwide.

In preclinical animal studies, oral administration of ANA971 resulted in higher levels of isatoribine in the blood than were present after oral administration of isatoribine itself. The objectives of this clinical trial are to assess safety and pharmacokinetics in healthy volunteers following oral administration of ANA971.

"Initiation of this clinical trial represents another important step toward our goal of improvement of HCV patient care, and builds on the results of clinical work we have conducted with isatoribine," said Devron Averett, Ph.D., Senior Vice President of Drug Development for Anadys.

About isatoribine (ANA245)
Isatoribine is a nucleoside analog Anadys is evaluating in ongoing clinical trials for the treatment of HCV infections. Isatoribine represents one of a new class of drugs being developed by Anadys to regulate innate immunity, combat HCV infection, and overcome limitations of current anti-HCV therapies. Anadys believes isatoribine interacts with a specific receptor, Toll-like receptor 7, or TLR7, that is present on certain immune system cells. Although results of initial clinical trials may not be predictive of future results, interim results of the Phase 1B clinical trial show that isatoribine is biologically active in adults with chronic HCV infection and results from dosing a cohort of six HCV infected patients with 800mg of isatoribine showed a statistically significant reduction of viral load (p=0.03) at the end of one week, with a median change in viral load from baseline of -0.94 log10 units(a). Anadys is currently enrolling patients for an isatoribine Phase I/II study.

About hepatitis C
HCV causes inflammation of the liver and degradation of liver function. HCV infection is currently the most common chronic blood-borne infection in the United States. Approximately 2.7 million people in the United States are chronically infected with HCV, and it causes 10,000 to 12,000 deaths a year in the United States. The Centers for Disease Control and Prevention, or CDC, estimates the annual mortality rate in the United States could increase to 38,000 by the year 2010, surpassing the number of deaths attributed annually to HIV/AIDS. HCV is transmitted primarily through significant or repeated exposures to infected blood. Approximately two thirds of new infections progress to chronic infection. Chronic HCV infection may also progress to more serious complications such as cirrhosis of the liver, liver cancer, and death.

Source: Anadys Pharmaceuticals, Inc.

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