Research & Development
Marinus Pharmaceuticals Resumes Phase 3 RAISE Trial in Status Epilepticus
6 May 2022 - - US-based pharmaceutical company Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) has resumed screening and recruitment for the Phase 3 RAISE (Randomized Therapy in Status Epilepticus) trial in refractory status epilepticus, the company said.

The company continues to expect topline RAISE trial results in the second half of 2023.

Marinus announced in February that it was pausing recruitment in the RAISE trial after routine stability monitoring showed visible particulates of aluminum phosphate in the drug solution.

During the pause, the chair of the independent Data Monitoring Committee for the trial reviewed the clinical safety data and determined no concerning safety events were identified in patients already treated with the batches of IV ganaxolone.

The trial has resumed utilizing new batches of the current IV formulation. Marinus has implemented a reduced shelf life of 12 months.

In agreement with the US Food and Drug Administration, ganaxolone clinical supplies will be stored under refrigerated conditions for the entire duration of clinical use.

Marinus anticipates modifying the IV ganaxolone formulation with a new buffer by end of 3Q22, targeting a shelf life of at least 24 months.

The company continues to expand the number of participating clinical trial sites for the RAISE trial in the US and Canada and is working closely with key investigators and site coordinators to support enrollment efficiencies with more than 50 sites now activated.

The resupply will also allow the Phase 2 RESET (Researching Established Status Epilepticus Treatment) trial to continue to advance.

The trial is on track to enroll the first patient in the second half of 2022. The Phase 3 RAISE II trial to support a potential marketing authorization application for RSE remains on track to commence in the first half of 2023 and is expected to utilize the anticipated new formulation of IV ganaxolone.

As previously disclosed, the clinical supply interruption did not affect ganaxolone's oral suspension formulation.

Ganaxolone development in the RAISE trial is being funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant secretary for Preparedness and Response at the US Department of Health and Human Services, under contract number 75A50120C00159.

Status epilepticus is a condition characterized by prolonged or repetitive seizures which, if treatment is delayed or ineffective, may result in medical or neurologic complications.

SE is a neurologic emergency affecting between 75,000 150,000 patients in the US each year. Benzodiazepines are the first-line treatment for SE.

If these are not successful in terminating SE, one or more IV AEDs are administered as the second line of treatment. If treatment with the first IV AED following benzodiazepines is ineffective, the patient is considered to have refractory SE.

Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects.

It 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.
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