Marinus Pharma (MRNS) Reports First Patient Enrollment in Pivotal Phase 3 Clinical Trial of IV Ganaxolone in Refractory Status Epilepticus
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Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced the enrollment of the first patient in a Phase 3 clinical trial of IV ganaxolone (RAISE trial) for the treatment of refractory status epilepticus (RSE), a life-threatening occurrence of continued or intermittent seizures lasting more than five minutes in duration without recovery of consciousness. RSE is considered a medical emergency that can cause permanent brain damage or death if not quickly controlled.
The RAISE trial is a randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of IV ganaxolone in RSE patients who have failed benzodiazepines and two or more second line intravenous antiepileptic drugs (AEDs). The study will examine the proportion of participants with RSE who experience status epilepticus cessation within 30 minutes of initiation of IV ganaxolone as well as the rate of progression to IV anesthesia. Cessation will be measured and determined by clinical and EEG findings.
Marinus also announced an agreement with Ceribell, Inc. that will place the handheld Ceribell Rapid Response EEG system in up to 80 U.S. hospitals participating in its study. The electroencephalogram (EEG) devices are designed to be compact and easy to use and will facilitate the rapid diagnosis of nonconvulsive SE, which is confirmed by EEG demonstration of ongoing ictal activity.
The Ceribell Rapid Response EEG system is intended to provide bedside clinicians the ability to quickly triage and continuously monitor patients at risk for seizures. Within the RAISE trial, it will allow clinicians to rapidly establish a diagnosis of nonconvulsive SE in the absence of immediate availability of conventional EEG. The Ceribell 20-minute certification video trains the hospital neurology team members to install the Ceribell Rapid Response EEG headband in less than seven minutes. The headband collects EEG data via a web-based portal, allowing the hospital neurology team to access the data remotely.
Ganaxolone development for RSE is 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 U.S. Department of Health and Human Services under contract number 75A50120C00159.
About the RAISE Trial
The Phase 3 RAISE Trial is a randomized, double-blind, placebo-controlled trial in status epilepticus (SE) patients who have failed benzodiazepines and two or more second line intravenous AEDs. Approximately 80 study sites in hospitals across the U.S. will participate. The trial is designed to enroll approximately 125 patients, who will be randomized to receive ganaxolone or placebo added to standard of care. With this number of participants, the study is designed to provide over 90 percent power to detect a 30 percent efficacy difference between ganaxolone and placebo.
The co-primary endpoints for the RAISE trial are (1) proportion of patients with SE cessation within 30 minutes of treatment initiation without other medications for the treatment of SE, and (2) proportion of patients with no progression to IV anesthesia for 36 hours following treatment initiation.
About Status Epilepticus (SE)
SE 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 – 150,00 patients in the U.S. 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 (RSE).
About the Ceribell Rapid Response EEG System
The Ceribell Rapid Response EEG System consists of a 10-electrode (8-channel) headband, an EEG recorder with Brain Stethoscope feature and a cloud portal for storing and reviewing EEGs. This simplified configuration of EEG enables easy access to EEG within minutes. The Ceribell EEG System received FDA 510(k) clearance in 2017 and is commercially available in the U.S.
Ceribell, Inc. (www.ceribell.com), is headquartered in Mountain View, CA. Ceribell is focused on making EEG widely available, more efficient, and more cost-effective to improve the diagnosis and treatment of patients at risk for seizures.
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