Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial Comparing Seltorexant (MIN-202) Versus Quetiapi...
December 21 2017 - 8:00AM
YASTESTMinerva Neurosciences Announces Enrollment of First
Patient in Phase 2b Trial Comparing Seltorexant (MIN-202)
Versus Quetiapine as Adjunctive Therapy to Antidepressants in
Patients With Major Depressive Disorder
WALTHAM, Mass., Dec. 21, 2017 (GLOBE
NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a
clinical-stage biopharmaceutical company focused on the development
of therapies to treat central nervous system (CNS) disorders, today
announced the enrollment of the first patient in a Phase 2b
clinical trial (NCT03321526) comparing seltorexant (MIN-202) versus
quetiapine as adjunctive therapy in patients with major depressive
disorder (MDD) who have responded inadequately to antidepressant
therapy.
The primary objective of this multi-center,
double-blind, randomized, flexible-dose, parallel-group study is to
assess the efficacy of flexibly dosed seltorexant compared to
flexibly dosed quetiapine as adjunctive therapy to a baseline
antidepressant drug in delaying time to all-cause discontinuation
of study drug over a 6-month treatment period. Time to
all-cause discontinuation is defined as the number of days from
administration of the first dose of study drug to administration of
the last dose of study drug.
"Preclinical studies have demonstrated that
inhibition of orexin 2 receptors diminishes stress-induced
activation of the HPA (hypothalamic-pituitary-adrenal) axis, a
major part of the neuroendocrine system that is implicated in the
pathophysiology of mood disorders and controls reactions to
stress," said Dr. Remy Luthringer, chief executive officer of
Minerva. "We expect that this trial will provide important
clinical data on the potential role of an orexin 2 inhibitor in
treating major depressive disorder."
The trial consists of three phases: a screening
phase lasting up to four weeks, a six-month double-blind treatment
phase and a two-week follow-up phase. Approximately 100
patients 18 to 64 years of age are planned to be randomized at
approximately 34 sites in the U.S. to receive either flexibly dosed
seltorexant, 20 milligrams (mg) or 40 mg, or flexibly dosed
quetiapine XR, 150 mg or 300 mg. Subjects will continue to
take their baseline antidepressant therapy of either an SSRI
(selective serotonin reuptake inhibitor) or an SNRI
(serotonin-norepinephrine reuptake inhibitor) at the same dose
throughout the screening, double-blind and follow-up phases.
About Seltorexant
(MIN-202)
Seltorexant is a selective orexin 2 receptor
antagonist under co-development by Janssen Pharmaceutica NV and
Minerva as adjunctive therapy for MDD and for the treatment of
insomnia disorder. The orexin system in the brain is involved in
the control of several key functions, including metabolism, stress
response and wakefulness.
About Minerva
Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of a portfolio of products to treat CNS
diseases. Minerva's product portfolio includes: MIN-101, in
clinical development for schizophrenia; seltorexant (MIN-202), in
clinical development for insomnia and major depressive disorder
(MDD); MIN-117, in clinical development for MDD; and MIN-301, in
pre-clinical development for Parkinson's disease. Minerva's
common stock is listed on the NASDAQ Global Market under the symbol
"NERV." For more information, please
visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains
forward-looking statements which are subject to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
as amended. Forward-looking statements are statements that
are not historical facts, reflect management's expectations as of
the date of this press release, and involve certain risks and
uncertainties. Forward-looking statements include statements
herein with respect to: the timing and results of future clinical
milestones with seltorexant in major depressive disorder, including
the timing and scope of future clinical trials and results of
clinical trials with this compound; the timing and outcomes of
future interactions with U.S. and foreign regulatory bodies; our
ability to successfully develop and commercialize seltorexant; the
sufficiency of our current cash position to fund our operations;
and management's ability to successfully achieve its goals.
These forward-looking statements are based on our current
expectations and may differ materially from actual results due to a
variety of factors including, without limitation, whether
seltorexant will advance further in the clinical trials process and
whether and when, if at all, it will receive final approval from
the U.S. Food and Drug Administration or equivalent foreign
regulatory agencies and for which indications; whether the results
of future clinical trials of seltorexant, if any, will be
consistent with the results of past clinical trials; whether
seltorexant will be successfully marketed if approved; whether any
of our therapeutic product discovery and development efforts will
be successful; our ability to achieve the results contemplated by
our co-development agreements; management's ability to successfully
achieve its goals; our ability to raise additional capital to fund
our operations on terms acceptable to us; and general economic
conditions. These and other potential risks and uncertainties
that could cause actual results to differ from the results
predicted are more fully detailed under the caption "Risk Factors"
in our filings with the Securities and Exchange Commission,
including our Quarterly Report on Form 10-Q for the quarter
ended September 30, 2017, filed with the Securities and
Exchange Commission on November 6, 2017. Copies of
reports filed with the SEC are posted on our website
at www.minervaneurosciences.com. The forward-looking
statements in this press release are based on information available
to us as of the date hereof, and we disclaim any obligation to
update any forward-looking statements, except as required by
law.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire
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