ContraVir Pharmaceuticals Inc. (NASDAQ: CTRV) watched its shares make a handy gain in Monday’s session after the company announced a positive development in its mid-stage hepatitis B (HBV) trial. Effectively, the ContraVir’s CMX157 received a positive recommendation from an independent Data Safety Monitoring Board (DSBM).
Now the company is enrolling the next dosing group in its head-to-head Phase 2a dose-escalation study comparing the safety and efficacy of CMX157 to tenofovir disoproxil fumarate (TDF, Gilead’s Viread) in patients with HBV. ContraVir expects to complete the remaining two escalation cohorts and report top-line results by year-end 2016.
Recently ContraVir had a big win in this trial when the company posted interim results. For a quick synopsis, CMX157 treated patients showed an average 99% reduction in HBV viral load compared to baseline. What was significant here was that the observed antiviral activity for CMX157 is comparable to that observed in TDF-treated patients, but at less than 10% of the dose. Notably, the 25 mg dose of CMX157 achieved comparable HBV viral load reduction to the standard 300 mg dose of Viread.
Based on CMX157’s favorable safety and tolerability in this study, as well as in a completed Phase 1b study in healthy volunteers, the DSMB approved proceeding to a higher dose in the ongoing Phase 2a dose escalation trial per study protocol.
James Sapirstein, CEO of ContraVir, commented:
Coupled with our recent demonstration of clinical proof of concept for CMX157 in HBV patients, the DSMB’s confirmation of CMX157’s safety profile continues to build the case for this drug’s potential as a cornerstone for combination therapy to cure HBV. We look forward to reporting final Phase 2a data by year end, and continue to believe that CMX157 has the ideal attributes needed for use as a component of a future combination drug strategy where drug-drug interactions put high demands on safety.
Shares of ContraVir were trading up about 18% at $2.31 on Monday, with a consensus analyst price target of $5.00 and a 52-week trading range of $0.75 to $2.55.