Marinus Pharmaceuticals recently announced the continuation of its Phase 3 RAISE trial for intravenous (IV) ganaxolone in treating refractory status epilepticus (RSE) following an interim analysis. Despite not meeting pre-defined stopping criteria, Marinus plans to complete enrollment to around 100 patients, with results anticipated in summer 2024. The outcome will determine further development plans for IV ganaxolone.
Marinus also provided business updates. The Phase 3 TrustTSC trial for ZTALMY® oral suspension for tuberous sclerosis complex is expected to complete enrollment in mid-May 2024, with topline data in the first half of Q4 2024. Marinus is developing a second-generation ganaxolone formulation with potential advantages in safety and dosing.
• RAISE trial continues after interim analysis; enrollment to be completed at 100 patients.
• TrustTSC trial enrollment expected to conclude in mid-May 2024; topline data on track for H1 Q4 2024.
• ZTALMY® commercial launch is ongoing, with strong preliminary Q1 2024 revenue.
• Cost reduction initiatives are being reviewed to enhance the company’s financial position.
• Marinus is exploring second-generation ganaxolone formulation with potential therapeutic advantages.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
