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Minerva Neurosciences, Inc.: Minerva Neurosciences Announces Positive Top Line Results From Phase Ib Clinical Trial in Major Depressive Disorder With MIN-202

Treatment with selective orexin-2 receptor antagonist observed to be well
tolerated and to improve symptoms of depression, independent from its effect
on sleep

WALTHAM, Mass., March 11, 2016 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc.
(NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the
development of therapies for central nervous system (CNS) disorders, today
announced positive top line results from a Phase Ib clinical trial in major
depressive disorder (MDD) with MIN-202 (JNJ-42847922), a selective orexin-2
receptor antagonist under joint development with Janssen Pharmaceutica NV.

"Treatment with MIN-202 was observed to result in consistent improvements in
the symptoms of depression in MDD patients in this trial," said Dr. Remy
Luthringer, president and chief executive officer of Minerva. "The results
pave the way to initiate a Phase IIb trial in patients suffering from MDD.
These improvements support the potential of MIN-202 to have a direct effect
on mood independent from its effect on sleep. We previously observed that
MIN-202 had a significant effect on sleep in our Phase IIa trial in patients
suffering from insomnia disorder."

The Phase 1b trial was a randomized, multi-center, double-blind, parallel
group, diphenhydramine- and placebo-controlled study to evaluate the effect
of MIN-202 in MDD outpatients 18-65 years of age. Forty-eight participants
were enrolled in three groups that received doses of 20 milligrams (mg) of
MIN-202 daily, 25 mg of diphenhydramine daily (used as a positive control to
induce sedation) or placebo over four weeks.

MIN-202 was observed to be well tolerated by study participants over a
one-month treatment duration, with no new emerging safety signals and no
serious adverse events.

Consistently greater improvements in depressive symptomatology were observed
in patients randomized to receive MIN-202 compared to those randomized to
receive placebo (PLA) or diphenhydramine (DPH), as measured by clinician
administered rating scales, including the Hamilton Depression Rating Scale
(HDRS17). Core symptoms of depression (as measured by the HAM-D6) were
observed to be significantly improved in the MIN-202 arm when compared with
the PLA arm.

The primary endpoint was safety and tolerability, and secondary endpoints
included assessments of depressive symptomatology, cognition and sleep. The
trial was conducted at seven clinical sites in Europe. Only top line results
with respect to safety, tolerability and efficacy on depressive
symptomatology are reported in this press release. Complete results are
planned for peer-reviewed presentation in the future.

MIN-202 is also under development to treat primary insomnia disorder.
Recently announced top line data from a Phase IIa trial in this indication
included statistically significant improvements in sleep efficiency (SE) as
measured by objective polysomnography, the primary endpoint of the trial,
observed in study patients treated with MIN-202, with an acceptable safety
and tolerability profile, compared to patients treated with placebo.

Minerva entered into a co-development and license agreement with Janssen in
February 2014 covering MIN-202 and other orexin-2 compounds. Under this
agreement, Minerva has an exclusive license to these compounds in the
European Union, Switzerland, Liechtenstein, Iceland and Norway. Janssen has
exclusive rights to these compounds worldwide outside of these territories.

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
Phase IIb development for schizophrenia; MIN-202 (JNJ-42847922), in Phase IIa
and Phase Ib development for insomnia and adjunctive treatment of MDD,
respectively; MIN-117, in Phase IIa 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

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 regarding MIN-202; the timing of future
clinical trials and results of clinical trials regarding MIN-202; the
clinical and therapeutic potential of MIN-202; our ability to successfully
develop and commercialize MIN-202; 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 only predictions and
may differ materially from actual results due to a variety of factors
including, without limitation, whether final data from the Phase Ib MIN-202
trial will be consistent with the preliminary results, whether MIN-202 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 MIN-202 will be successfully marketed if approved;
whether our therapeutic product discovery and development efforts will be
successful for MIN-202; 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, 2015, filed with the
Securities and Exchange Commission on November 5, 2015. Copies of reports
filed with the SEC are posted on our website at
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.

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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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