Marinus Completes Enrollment in its Magnolia Postpartum Depression Study

25 September 2018

RADNOR, Pa.Sept. 25, 2018 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced it has recently completed enrollment in its Magnolia Study – a Phase 2 clinical trial evaluating the safety, pharmacokinetics and efficacy of ganaxolone in women with postpartum depression.

“The completion of enrollment in our Magnolia Study is an important milestone in studying PPD, for which there is currently no approved treatment,” said Christopher Cashman, chairman and CEO of Marinus Pharmaceuticals. “This study is the first to examine how ganaxolone IV behaves in this patient population, bringing us closer to developing a convenient dosing regimen so new mothers can receive treatment in the hospital or at home, caring for their newborns. With enrollment completed, top-line data from the study is on-track to be reported in the fourth quarter of 2018.”

The double-blind, placebo-controlled Magnolia Study is designed to test whether ganaxolone can be used to treat PPD by administering the drug intravenously for 60 hours in women diagnosed with the disorder. Patients will undergo a 30-day follow-up visit after treatment.

After childbirth, women experience a steep drop in the hormones that increase during pregnancy, a rapid hormonal change thought to be linked with depression. Approximately 15 percent of women experience postpartum depression (PPD) within a year of childbirth, a condition affecting a mother’s ability to care for their child, the child’s cognitive development, and negatively impacting a mother’s long-term health.

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 positive allosteric modulator of GABAA that acts on a well-characterized target in the brain known to have anti-seizure, anti-depressant 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.  Marinus has initiated the first ever pivotal study in children with CDKL5 deficiency disorder, a rare form of epilepsy, and is currently conducting studies in patients with postpartum depression and refractory status epilepticus. 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, the attainment of clinical trial results that will be supportive of regulatory approvals, and other matters, including the development of formulations of ganaxolone, and the availability or potential availability of alternative products or treatments for conditions targeted by the Company 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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