Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial of Seltorexant (MIN-202) as Adjunctive Therapy in Patients With Major Depressive Disorder
(Thomson Reuters ONE) -
WALTHAM, Mass., Sept. 05, 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 of
seltorexant (MIN-202) as adjunctive therapy to antidepressants in adult patients
with major depressive disorder (MDD) who have responded inadequately to
antidepressant therapy.
The primary objectives of this multi-center, double-blind, randomized, parallel
group, placebo-controlled, adaptive-dose finding study are:
* to assess the dose-response relationship and antidepressant effects of up to
three doses of seltorexant; and
* to assess the safety and tolerability of seltorexant compared to placebo as
described in clinicaltrials.gov: NCT03227224.
"An important differentiator of seltorexant is its specificity for the orexin 2
receptor subtype, which is known to have a key role in controlling brain
structures and pathways involved in mood and insomnia," said Dr. Remy
Luthringer, president and chief executive officer of Minerva. "This trial
follows the observed improvements in mood in an earlier study carried out in
depressed patients who received seltorexant."
The trial consists of three phases: a screening phase lasting up to four weeks,
a six-week double-blind treatment phase and a two-week post-treatment follow-up
phase. Approximately 280 patients are planned to be enrolled at more than 85
clinical sites in the U.S., Europe, Russia and Japan.
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 proprietary compounds include: 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 MIN-202 in insomnia and 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 agreements with Janssen related to seltorexant;
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 June 30, 2017, filed with the Securities and Exchange Commission on August
3, 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
Datum: 05.09.2017 - 14:00 Uhr
Sprache: Deutsch
News-ID 558750
Anzahl Zeichen: 6410
contact information:
Town:
Waltham
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