BARDA Contract

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, has awarded Marinus Pharmaceuticals $51 million of an $84 million contract to fund the company’s Phase 3 trial in refractory status epilepticus.

On a successful development, BARDA and Marinus could potentially negotiate a procurement agreement for a supply of ganaxolone for potential response to nerve agent exposure threats.


September 2020 announcement

BARDA and Marinus Partner to Develop New Treatment for Refractory Seizures


FAQs

Q: How will the Phase 3 SE trial be related to or different from the BARDA trial for the effects of nerve agents?

A: An FDA approval for the use of ganaxolone commercially would support the use of ganaxolone for nerve agent toxicity with successful completion of additional further pre-clinical studies. The Phase 3 study will investigate the use of ganaxolone in the treatment of refractory status epilepticus caused by medical conditions as a surrogate for refractory status epilepticus caused by nerve agent exposure. Parallel to the Phase 3 clinical study, Marinus will conduct appropriate preclinical studies in standard of care (benzodiazapine refractory resistant) models of nerve agent-induced seizures.

Q: What is the primary endpoint of the Phase 3 SE trial and what will the primary endpoint be for the BARDA contract trial?

A: The primary endpoint for Marinus’ Phase 3 clinical study in SE is a proportion of participants with refractory status epilepticus cessation within 30 minutes of ganaxolone’s initiation without additional medications for acute treatment of SE. SE cessation is determined by clinical and EEG findings.

In addition, the Phase 3 trial aims to avoid patients’ progression to IV anesthesia for the treatment of their SE for 36 hours following ganaxolone’s administration.  

Q: What is the timeline of the contract and the Phase 3 refractory status epilepticus trial? When can we expect data?

A: See the pipeline chart