The Phase Ib clinical trial is a double-blind, placebo-controlled study that will evaluate the tolerability, pharmacokinetics and viral kinetics of multiple, ascending doses of ANA598 over a period of three days. Anadys expects to enroll approximately 30 patients in the study of ANA598 at doses of 200mg bid (twice-a-day), 400mg bid and 800mg bid.
In the Phase Ib monotherapy study, ANA598 will be administered to naive genotype 1a and 1b patients over three days, at doses of 200mg bid, 400mg bid or 800mg bid.
A total of 10 patients are planned to be enrolled in each of the three cohorts – eight on active treatment and two on placebo. Anadys expects to have viral load data from all three cohorts in the first quarter of 2009. Anadys may elect to explore other dose levels of ANA598 and/or once-daily dosing based on data from the first three cohorts.
James Freddo, senior vice president of drug development and chief medical officer of Anadys, said: “We look forward to building upon these results and testing the compound in hepatitis C virus (HCV) patients, first in this monotherapy study and subsequently in combination studies. We expect the maximal benefit of direct antivirals to be realized when used in combination regimens incorporating multiple anti-HCV agents.”