Marinus Pharmaceuticals Completes Patient Recruitment in Phase 3 Clinical Trial of Ganaxolone in Focal Onset Seizures

Print 16 December 2015


RADNOR, Pa., Dec. 16, 2015 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced that it has completed patient recruitment for the Phase 3 clinical trial of ganaxolone, a CNS-selective GABAA modulator, in adults with drug-resistant focal onset seizures. Sites participating in this global study have completed screening patients. After establishing eight weeks of baseline seizure frequency, patients randomized in the study undergo a two-week titration period followed by a twelve-week maintenance period. The Company anticipates announcing top-line results from the study in mid-2016.

Christopher M. Cashman, Chief Executive Officer of Marinus Pharmaceuticals, stated, “Completing patient recruitment in our Phase 3 trial is an important milestone in the clinical development of our ganaxolone program, as well as for the epilepsy community. This Phase 3 study is designed similarly to our Phase 2 study that was conducted in patients experiencing drug-resistant seizures for more than 25 years, and where ganaxolone met the primary endpoint and was safe and well-tolerated.  In addition, a responder analysis showed that 40% of the ganaxolone-treated patients achieved at least 30% reduction in mean weekly seizure frequency. We look forward to announcing top-line results from this study in mid-2016.”

The global, randomized, placebo-controlled Phase 3 study is designed to evaluate the effectiveness and safety of ganaxolone as an adjunctive therapy in adults with drug-resistant focal onset seizures. Approximately 350 patients will be randomized to receive either 1,800 mg/day of ganaxolone or placebo for 12 weeks. The primary endpoint of the study is percent change in seizure frequency per 28 days relative to the baseline. Further information about the Phase 3 study can be found on ClinicalTrials.gov, using Identifier NCT01963208.

Albena Patroneva, M.D., Chief Medical Officer of Marinus Pharmaceuticals, commented, “Approximately 30-35% of patients do not attain acceptable seizure control with single or multiple antiepileptic drugs currently prescribed. Additionally, many patients struggle with tolerability and concerns over reproductive toxicities associated with their prescribed seizure medications. We believe ganaxolone, with its differentiated mechanism of action and safety profile, has the potential to help patients achieve better seizure control.”

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 planned to enter clinical trials in 2016 and is being developed 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 is being evaluated in a Phase 3 multi-national clinical trial as adjunctive treatment of focal onset seizures in adults.  Ganaxolone capsule and liquid are being studied in orphan pediatric indications with comorbidities in seizures and behavior disorders – PCDH19 epilepsy and Fragile X Syndrome. For more information visit www.marinuspharma.com.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Words such as “may”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “believe”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.  Examples of forward looking statements contained in this press release include, among others, statements regarding our interpretation of preclinical studies, development plans for our product candidate, including the development of dose forms, the clinical trial testing schedule and milestones, the ability to complete enrollment in our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.  Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical trials, the timing of the clinical trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters, including the development of formulations of ganaxolone, that could affect the availability or commercial potential of our drug candidates.  Marinus undertakes no obligation to update or revise any forward-looking statements.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission.

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