FDA ACCEPTS IND APPLICATION FROM ANADYS
Anadys Pharmaceuticals announced that the FDA has accepted its investigational
new drug application to evaluate its lead compound, ANA975. Anadys has a joint
development and commercialization collaboration with Novartis for ANA975, an
oral toll-like receptor 7 (TLR7) agonist.
ANA975 is an oral prodrug of isatoribine, a small molecule TLR7 agonist that has been administered intravenously to 68 subjects in clinical trials. Results from a clinical trial in HCV infected patients receiving intravenous isatoribine over a one-week period indicated that isatoribine treatment resulted in an average 83 percent decrease in plasma viral load of the hepatitis after the one week of treatment. Data from a recently completed Phase I clinical trial of ANA975 in 36 subjects indicate that the bioavailability of ANA975 is virtually complete and conversion to isatoribine in plasma is rapid and efficient, delivering levels of isatoribine that have been shown to be clinically relevant.