Ganaxolone and Diazepam Administered Intravenously Synergistically Block Seizures in Animal Model of Status Epilepticus
November 15 2016 - 7:30AM
Data Presented at Neuroscience 2016
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical
company dedicated to the development of innovative therapeutics to
treat epilepsy and neuropsychiatric disorders, presented
preclinical data showing that the combination of its CNS-selective
GABAA modulator ganaxolone and diazepam administered intravenously
(IV) produced a synergistic effect in blocking pilocarpine-induced
seizures in a benzodiazepine refractory model of status epilepticus
(SE). Marinus is developing ganaxolone IV for the treatment of
status epilepticus, a life-threatening medical emergency associated
with high mortality and limited treatment options. The data was
presented during a poster presentation at Neuroscience 2016, the
annual meeting of the Society for Neuroscience, which occurred
November 12 – 16, 2016 in San Diego, CA.
The poster entitled, “Ganaxolone and diazepam
administered IV produce a synergistic anti-epileptic effect in
treatment refractory model of status epilepticus,” was presented by
Michael S. Saporito, Ph.D., a preclinical consultant to Marinus
Pharmaceuticals. The data in the poster demonstrated that
sub-therapeutic doses of diazepam and ganaxolone when administered
in combination 15 minutes after onset of status epilepticus
produced a partial or complete block of treatment-resistant status
epilepticus in a rat model of SE, a clinically translatable model
of this condition. Ganaxolone and diazepam plasma levels were
measured alone and in combination and were identical, indicating
that neither drug affected the pharmacokinetic disposition of the
other. In addition, the study suggests that the synergistic
enhancement of anti-epileptic activity occurred at the level of the
GABAA receptor.
Albena Patroneva, M.D., chief medical officer at
Marinus, commented, “The synergistic effect seen with the
combination of ganaxolone and diazepam has the potential to deliver
a meaningful combination for the treatment of status epilepticus,
where more than 30% of patients become resistant to
benzodiazepines. These results, along with previous preclinical
studies, show that ganaxolone IV not only has potential as a
standalone therapy in producing a complete block of status
epilepticus, but could also be used in combination with
benzodiazepines to produce a rapid break of continuous seizures. We
look forward to advancing our ganaxolone IV into clinical studies
for patients with status epilepticus.”
Following positive Phase 1 results of ganaxolone
IV in healthy volunteers, Marinus is preparing 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.
About Ganaxolone
Ganaxolone is a CNS-selective GABAA modulator
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 acts on a well-characterized synaptic and
extrasynaptic GABAA target known for its anti-seizure and
anti-anxiety activity. Ganaxolone has been studied in more
than 1,400 subjects, both pediatric and adult, at therapeutically
relevant dose levels and treatment regimens for up to two years. In
these studies, ganaxolone was generally safe and well tolerated,
with the most commonly reported adverse events of somnolence,
dizziness and fatigue.
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.
Marinus is currently evaluating ganaxolone in orphan pediatric
indications for the treatment of genetic seizure and behavior
disorders, and preparing to initiate Phase 2 studies in status
epilepticus, an orphan indication, and postpartum depression. 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.
CONTACT:
Company:
Lisa M. Caperelli
Senior Director, Investor Relations & Corporate Communications
Marinus Pharmaceuticals, Inc.
484-801-4674
lcaperelli@marinuspharma.com
Media Contact:
Tiberend Strategic Advisors, Inc.
Amy S. Wheeler
646-362-5750
awheeler@tiberend.com
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