Marinus Pharmaceuticals presents clinical data from pivotal phase 3 RAISE trial

Marinus Pharmaceuticals presented new data from the pivotal Phase 3 RAISE trial evaluating intravenous ganaxolone for the treatment of refractory status epilepticus RSE at the Neurocritical Care Society NCS Annual Meeting. Topline data demonstrating that the trial met one of two co-primary endpoints were reported in June 2024. In the RAISE trial patients with RSE that failed at least two antiseizure medications were randomized to IV ganaxolone or placebo in addition to standard of care treatment. The co-primary endpoints were the proportion of patients with status epilepticus cessation within 30 minutes and the proportion of patients not progressing to IV anesthesia within 36 hours of study drug initiation. …Dr. Foreman continued, “With 80% of patients achieving SE cessation within 30 minutes of IV ganaxolone administration and a median time to SE cessation of 4.2 minutes, there is clear indication of rapid antiseizure activity in highly refractory patients. Although the RAISE trial did not achieve statistical significance on the second coprimary endpoint, other secondary measures of durability, such as reductions in EEG seizure burden and proportion of patients with no treatment escalation within 24 hours, showed clinically meaningful benefits.”