Marinus Completes Enrollment in its Magnolia Postpartum Depression Study
September 25 2018 - 7:30AM
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
PharmaceuticalsMarinus 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. Please follow us on
Twitter: @MarinusPharma.
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.
CONTACT: |
|
|
Lisa M. Caperelli |
|
Executive Director,
Investor & Strategic Relations |
|
Marinus
Pharmaceuticals, Inc. |
|
484-801-4674 |
|
lcaperelli@marinuspharma.com |
Marinus Pharmaceuticals (NASDAQ:MRNS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Marinus Pharmaceuticals (NASDAQ:MRNS)
Historical Stock Chart
From Apr 2023 to Apr 2024