Marinus Pharmaceuticals (NASDAQ: MRNS) is trading more than 6% higher this morning after the company announced favorable results from its phase 1 dose-escalation study in which ganaxolone intravenous (IV) achieved dose levels targeted for efficacy in patients with status epilepticus (SE) – a life-threatening medical emergency associated with high mortality and limited treatments – and other indications. The phase 1 clinical study enrolled 36 subjects at Duke University Medical Center and was designed to determine the pharmacokinetics (PK), pharmacodynamics (PD), and safety of ganaxolone IV administered as an ascending bolus dose (Stage 1) or continuous infusion (Stage 2). Marinus is making preparations to commence its Phase 2 clinical study in patients with SE in 2017. Earlier this year, the U.S. Food and Drug Administration granted Orphan Drug Designation to ganaxolone IV for the treatment of SE.
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About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety and convenient dosing, to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders. Ganaxolone is a CNS-selective GABAA modulator that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone IV is advancing into Phase 2 studies to treat status epilepticus. Ganaxolone IV is complemented by its oral dose forms, providing the potential for IV-to-oral continuation therapy for patients transitioning from acute care to outpatient settings. Ganaxolone capsule and liquid is being studied in orphan pediatric indications with comorbidities in seizures and behavior disorders – PCDH19, CDKL5, Lennox-Gastaut Syndrome and Fragile X Syndrome. For more information visit www.marinuspharma.com
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