The trial is designed to enroll 60 treatment-naïve patients. The sequential dose- escalation format consists of 10 patients per cohort receiving four weeks of a once-daily dose of 5, 10, 25, 50, and 100 mg of CMX157, respectively, plus two patients per cohort receiving 300 mg of TDF, the standard therapeutic dose of Viread.
The patients have successfully completed the 5-mg and 10-mg cohorts. The new interim data were derived from 10 HBV-infected patients who completed 14 days of once-daily oral dosing of 25 mg of CMX157, and two HBV patients treated for 14 days of oral dosing with 300 mg TDF. The CMX157-treated patients showed an average 99% reduction in the HBV viral load compared with baseline. Significantly, the observed antiviral activity for CMX157 was comparable with that observed in TDF-treated patients, but at one-twelfth the dose (25 mg of CMX157 versus the standard 300 mg of TDF).