Marinus Drug Fails To Meet Goals In Phase 3 Trial In Focal Onset Seizures

(RTTNews) - Marinus Pharmaceuticals Inc. (MRNS) announced results from its Phase 3 clinical trial in adults with drug-resistant focal onset seizures. In this trial, ganaxolone did not meet the primary endpoint of demonstrating a statistically significant difference from placebo. Consistent with previously conducted studies, ganaxolone was generally safe and well tolerated.

Marinus said it plans to discontinue its program in adult focal onset seizures and focus its efforts on advancing ganaxolone in status epilepticus and pediatric orphan indications.

Christopher Cashman, chief executive officer of Marinus Pharmaceuticals, commented, "We are disappointed with the outcome of this study, and the unfortunate impact on the epilepsy community and particularly the patients suffering from drug-resistant focal onset seizures who are benefiting from ganaxolone treatment. We remain confident in the safety profile of ganaxolone and its ability to effectively reduce seizures in targeted patient populations."

The study missed its primary endpoint of percent change in the 28-day seizure frequency from baseline (p=0.1537). The median percent reduction of focal onset seizures in the ganaxolone group was 21.28% compared to 10.25% with placebo during the titration and the 12-week treatment period.