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.
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May