Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) has announced the fulfillment of the FDA’s protocol-specific questions for its registration third phase RAISE trial in refractory status epilepticus (RSE). This allows the company to commence enrolment in the clinical trial.
Marinus to commence enrolment in RAISE study
The company submitted a protocol amendment in July to the FDA for the study for using IV ganaxolone in treating RSE. After its recent meeting with the FDA, Marinus expects to commence patient enrollment in the RAISE study in October. So far, the company has picked 55 out of the expected 80 clinical sites where it will conduct the trial, and topline data from the study is expected in 1H 2022.
Joe Hulihan, the company’s chief medical officer, stated that in the recent second phase study in RSE, they were able to control status epilepticus at a median time of five minutes after ganaxolone treatment. No patients progressed to IV anesthesia to control seizures within 24 hours. Hulihan said there is an unmet need for RSE treatment, and the company is eager to commence Phase 3, a clinical trial for the indication.
Marinus appoints Henri Vaitkevicius to the clinical development team
In other developments, the company has announced Dr. Henri Vaitkevicius to the Vice President, Clinical Development positions, and will report to Hulihan. Dr. Vaitkevicius has been a clinician at Massachusetts General Hospital, Harvard University School. He is credited to be the first physician who successfully treated a patient with super refractory status epilepticus using a neurosteroid.
He will join Maciej Gasior and Igor Grachev to expand the company’s clinical development team. They both hold the VP Clinical Development title. Hulihan said that Vaitkevicius has served the company’s advisory board and as the lead investigator of the phase 2 RSE trial, he has adequate experience on the science behind the company’s research for the development of ganaxolone as a treatment alternative for patients having severe seizure disorders. The Biomedical Advanced Research and Development Authority (BARDA) is funding the development of ganaxolone for RSE.