ContraVir Pharma (CTRV) Begins Enrollment in CMX157 Phase 2a Dose-Escalation Study

October 17, 2016 6:37 AM EDT
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ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV) announced that following a positive recommendation from an independent Data Safety Monitoring Board (DSMB), the company has begun enrolling the next dosing group in its head-to-head Phase 2a dose-escalation study comparing the safety and efficacy of ContraVir's CMX157 to tenofovir disoproxil fumarate (TDF, marketed by Gilead Sciences as Viread®) in patients with chronic hepatitis B (HBV). ContraVir expects to complete the remaining two escalation cohorts and report top-line results by year-end 2016.

The DSMB conducted an independent review of the safety, tolerability and pharmacokinetic profile of CMX157 from the completed 5 mg, 10 mg and 25 mg dosing groups of ContraVir's ongoing, 28-day, Phase 2a study in HBV-infected patients. Based on CMX157's favorable safety and tolerability in this study as well as in a completed Phase 1b study in healthy volunteers, which dosed up to 100 mg of CMX157 per day, the DSMB approved proceeding to a higher dose in the ongoing Phase 2a dose escalation trial per study protocol.

"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," said James Sapirstein, CEO of ContraVir. "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."

ContraVir recently announced positive interim data demonstrating strong antiviral activity and favorable safety and pharmacokinetics for CMX157. Notably, a 25 mg dose of CMX157 achieved comparable HBV viral load reduction to the standard 300 mg dose of Viread®, but with significantly reduced systemic levels of active tenofovir. Results from the completed Phase 1b and ongoing Phase 2a clinical trials suggest that CMX157 is a highly potent HBV antiviral that may mitigate the risk of kidney and bone toxicities that are associated with Viread®.

CMX157 Phase 2 Clinical Trial Design

The Phase 2a multiple ascending dose clinical trial, which is designed to enroll 60 treatment-naïve patients with chronic HBV infection, compares CMX157 to tenofovir disoproxil fumarate (TDF, Gilead's Viread®). 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, respectively, of CMX157, plus two patients per cohort receiving 300 mg of TDF, the standard therapeutic dose of Viread®.

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