US-based biopharmaceutical company ContraVir Pharmaceuticals has initiated dosing patients in its head-to-head Phase lla trial comparing its CMX157 to tenofovir DF (TDF), marketed by Gilead Sciences as Viread to treat chronic hepatitis B (HBV).
The trial plans to enrol 60 treatment-naïve patients with a chronic HBV infection.
It will compare sequentially escalating doses of CMX157, starting at a 5mg daily CMX157 dose compared to a 300mg daily dose of TDF, the standard daily dose of Viread.
During the trial, ten patients per cohort will receive four weeks of a once-daily dose of either 5mg, 10mg, 25mg, 50mg or 100mg of CMX157, and two patients per cohort will receive 300mg of TDF, the standard dose of Viread.
The trial is expected to end by the last quarter of this year.
ContraVir CEO James Sapirstein said: "We anticipate that this study will reflect the positive findings from our animal and in vitro studies, which demonstrated superior potency against HBV and significant liver targeting, allowing the potential for CMX157 to reduce the risk of kidney and bone toxicities by being more effective at lower doses.
"We expect the current study will validate CMX157's potential to be dosed lower than Viread, and at the same or a lower dose than Gilead's tenofovir alafenamide, or TAF.
"In addition, we are happy to report that the Phase 1b study continues to advance smoothly and in line with our expectations into the final 100mg dosing group, without any safety or tolerability concerns."
In a separate Phase Ib, multiple-ascending, dose-clinical study, ContraVir has administered 50mg of CMX157 to a healthy group of patients and have proceeded to the fifth and final dosing group of 100mg.