Marinus Pharmaceuticals Inc (NASDAQ:MRNS) expects data from the RAISE Phase 3 trial of ganaxolone in refractory status epilepticus in 2H of 2023. Earlier data from the trial was expected in 2H of 2022.
- The delay is due to the impact of the COVID-19 omicron variant and an interruption of clinical supply material associated with IV ganaxolone.
- Marinus has temporarily paused the RAISE trial after routine monitoring of stability batches of clinical supply material indicated that it became necessary to reduce the shelf life to less than the anticipated 24-months to meet product stability testing specifications.
- Related: Marinus' Oral Ganaxolone Lowers Seizure Frequency In Genetic Disorder.
- The company is targeting resupply of clinical trial material by the end of Q2 2022.
- Separately, Marinus is implementing improvements in the manufacturing process to achieve a 24-month or greater product shelf life for IV ganaxolone.
- Timing for the Phase 2 RESET trial of adjuvant use of ganaxolone in established status epilepticus and the Phase 3 RAISE II trial (for European registration) in status epilepticus is expected to incur a six-month initiation delay.
- The clinical supply interruption affects the IV formulation of ganaxolone and the IV clinical programs. It does not affect ganaxolone's oral suspension formulation, for which Marinus has submitted an FDA marketing application for seizures associated with CDKL5 deficiency disorder, rare, genetic epilepsy.
- The Prescription Drug User Fee Act action date is March 20.
- Price Action: MRNS shares traded 4.11% lower at $10.72 during pre-market trading on Wednesday.
