Marinus Pharma Says Phase 3 Trial Of IV Ganaxolone In RSE Meets First Co-primary Endpoint
(RTTNews) - Pharmaceutical company Marinus Pharmaceuticals, Inc. (MRNS) announced Monday topline results from the Phase 3 double-blind, randomized, placebo-controlled RAISE trial evaluating the safety and efficacy of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE).
RSE, in which prolonged continuous or rapidly recurring seizures do not respond to first- and second-line therapy, is associated with significant morbidity and mortality.
The RAISE trial met its first co-primary endpoint demonstrating rapid cessation of status epilepticus in a highly refractory patient population.
However, the trial failed to achieve statistical significance on the second co-primary endpoint of the proportion of patients not progressing to IV anesthesia.
The Company will continue to analyze the full RAISE dataset and plans to engage with the U.S. Food and Drug Administration to discuss a potential path forward for IV ganaxolone in RSE.
Marinus intends to continue to offer IV ganaxolone for patients with super refractory status epilepticus under emergency investigational new drug applications.
The Company expects cash and cash equivalents are sufficient to fund its operating expenses, including capital expenditure and working capital requirements, into the second quarter of 2025.
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