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Marinus Pharmaceuticals Announces Delay to RAISE Phase 3 Clinical Trial in Status Epilepticus and Associated IV Ganaxolone Clinical Trials
RAISE trial delayed due to impacts from COVID-19 variant and recent interruption in clinical supply material
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that due to the impact of the COVID-19 Omicron variant on hospital resources and an unexpected interruption of clinical supply material associated with IV ganaxolone, the RAISE, Phase 3, double-blind placebo-controlled trial for the treatment of status epilepticus, is now expected to be completed in the second half of 2023.
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. The Company is targeting resupply of clinical trial material by the end of the second quarter 2022. Separately, Marinus is implementing improvements in the manufacturing process with the goal of achieving a 24-month or greater product shelf life for IV ganaxolone.
COVID-19, and most recently the Omicron variant, have continued to impact hospital resources and have put a significant strain on hospital staff, particularly in intensive care units, where the RAISE trial is being conducted. This has led to slower than anticipated enrollment. Despite these issues, interest in the trial remains strong with 48 sites now activated and additional sites expected, including potential expansion into Canada.
As a result of these impacts, Marinus is revising its target for announcing top line data from the RAISE trial to the second half of 2023. 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, are both expected to incur a six-month initiation delay.
The clinical supply interruption affects the IV formulation of ganaxolone and the IV clinical programs. This supply issue does not affect ganaxolone’s oral suspension formulation or the Company’s New Drug Application (NDA), which was submitted in July to the U.S. Food and Drug Administration, for the treatment of seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy.
The Prescription Drug User Fee Act action date for the NDA is March 20, 2022.
As previously announced, Marinus will hold a Fourth Quarter Business Update on March 21, 2022, with a conference call at 8am Eastern Time.
For additional information about the conference call or about Marinus, please visit www.marinuspharma.com.
About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.