ContraVir Doses First Patients In Head-to-Head Trial Of CMX157 For Hepatitis B Treatment

ContraVir Pharmaceuticals, Inc. CTRV revealed Tuesday it dosed the first patients with chronic hepatitis B in its head-to-head Phase 2a trial versus its CMX157 to tenofovir DF. According to the company, the trial was the first to directly compare lower doses of CMX157 to the regular daily dose of Viread in hepatitis B patients. It would assess the potential for CMX157, given its superior potency, to be more effective at lower doses, as well as, potentially cut the risk of tenofovir-associated side effects.

ContraVir indicated the trial would conclude in the fourth quarter of the current year. Its Phase 2a would enroll a total of 60 treatment-naïve patients with chronic HBV infection. The company added that the trial comprised of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, and two patients per cohort receiving 300 mg of TDF, the standard dose of Viread.

The company's CEO, James Sapirstein, commented, "This marks the first time CMX157 will be dosed in HBV patients. 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."

He continued, "We expect the current study will validate CMX157's potential to be dosed lower than Viread, and at the same or lower dose than Gilead's tenofovir alafenamide, or TAF. In addition, we're happy to report that the Phase 1b study continues to advance smoothly and in line with our expectations into the final 100 mg dosing group, without any safety or tolerability concerns."