TLR7 Agonist against HCV | Hepatitis Central

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TLR7 Agonist against HCV

The Editors at Hepatitis Central
August 24, 2005

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Wow. Another promising candidate for more effective (and less toxic) HCV treatment.

We’ll keep you posted on this one, as well as any others coming down the pipeline.

Be sure to notice this excerpt:

“Worldwide sales for HCV products were an estimated $2.7 billion in 2003, yet current treatments for HCV may be ineffective in up to 50 percent of patients, and many treatments are associated with serious side effects.”

That $2.7 billion was in 2003 (it would be more now). This amount is what keeps drug companies looking for a better treatment.

Also notice they are estimating current therapies may be ineffective in up to 50% of patients. Compare that to the numbers your doctor is giving you.
This is part of the reason you need to stay informed.

Peer Reviewed Report in HEPATOLOGY Details Inhibition of Hepatitis C Virus and Immune Activation by a TLR7 Agonist

SAN DIEGO, Aug. 23 /PRNewswire-FirstCall/ — Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), reported the publication of the results of a Phase IB clinical trial of isatoribine (ANA245) in HEPATOLOGY(1), the official journal of the American Association for the Study of Liver Disease (http://www3.interscience.wiley.com/cgi-bin/abstract/111081950/ABSTRACT).

This peer-reviewed publication concluded that isatoribine treatment resulted in biological activity and a statistically significant antiviral effect with relatively few and mild side effects. “The manuscript describes the encouraging combination of good tolerability with desirable immunologic and anti-HCV activity that we observed for isatoribine,” said Yves Horsmans, M.D., Professor at Cliniques Universitaires St. Luc in Brussels and Principal Investigator of the study. “These results create strong interest in clinical evaluation of ANA975, the oral prodrug form of isatoribine that now is being jointly developed by Anadys and Novartis.” The Phase IB clinical trial was designed to test the safety and tolerability of isatoribine in patients chronically infected with HCV.

The study was a dose-escalating, open-label evaluation of isatoribine administered intravenously at 200 mg, 400 mg, 600 mg and 800 mg doses to 32 adults, most of whom received once daily dosing for seven days. The trial was conducted at two clinical centers in Western Europe. Patients participating in the study were either HCV-treatment naive or were partial responders to or relapsed from interferon-alpha, a component of the current standard of treatment. Study results showed that isatoribine demonstrated dose-dependent changes in immunologic biomarkers. The amount of HCV in the bloodstream, or plasma viral load, was significantly reduced in patients receiving 800 mg once daily for seven days.

Of the 12 patients in this 800 mg dose group, 10 were infected with HCV genotype 1, which is considered difficult-to-treat with current therapies. Isatoribine treatment was safe and well tolerated in the study, with no serious adverse events and a low frequency of side effects, although definitive conclusions regarding product safety cannot be made until the results of future clinical trials of longer duration in more patients are known. No patient altered isatoribine treatment or withdrew from the study due to adverse events or clinical laboratory abnormalities.

About Hepatitis C

Hepatitis C virus, the most common chronic blood-borne infection in the United States, causes inflammation of the liver and may progress to more serious complications such as cirrhosis of the liver, liver cancer and death. Approximately 2.7 million people in the United States are chronically infected with HCV, and the Centers for Disease Control (CDC) estimates that by the year 2010, the number of deaths attributed annually to HCV could surpass that due to HIV/AIDS.

Worldwide sales for HCV products were an estimated $2.7 billion in 2003, yet current treatments for HCV may be ineffective in up to 50 percent of patients, and many treatments are associated with serious side effects.

About Anadys Anadys Pharmaceuticals, Inc. (http://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 other serious infections. 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 HCV and HBV, and ANA380 for the treatment of HBV. In addition, Anadys’ therapeutic platform is designed to advance a strong and continual pipeline of drug candidates into the clinic.

1. Horsmans Y, Berg T, Desager J-P, Mueller T, Schott E, Fletcher SP, Steffy KR, Bauman LA, Kerr BM & Averett DR. “Isatoribine, an Agonist of TLR7, Reduces Plasma Virus Concentration in Chronic Hepatitis C Virus Infection”. Hepatology 2005; 42:724-731.

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