Coley reports encouraging phase I results in hepatitis

Actilon is a first-in-class Toll-like receptor 9 (TLR9) agonist initially being developed for the treatment of hepatitis C.

The phase Ia trial of Actilon in 40 healthy volunteers demonstrated that the compound is well tolerated over a wide dose range, and that small subcutaneous doses induce measurable, dose-related immune responses consistent with the known pharmacologic mechanisms of this new class of antiviral activity drugs.

The ongoing phase Ib study is evaluating anti-viral responses among chronic hepatitis C patients as well as the safety and tolerability of twice weekly Actilon over the same dose range. Of 18 patients evaluated to date at the 1, 4, and 10mg dose levels, six (33%) have demonstrated early viral level reduction equal to or better than 1.0 log decrease (or 90%) during the four weeks of treatment.

“The data confirm our expectations regarding Actilon’s TLR9-mediated antiviral activity,” said Dr John Whisnant, Coley’s senior vice president of drug development. “I am also encouraged by the fact that Actilon demonstrated antiviral activity even among patients with genotype 1 HCV, the viral genotype which is most difficult to treat. These results provide us with important insights on dosing regimens for further development.”