Minerva Neurosciences Announces Favorable Top Line Results From MIN-202 Phase 2A Clinical Trial in Insomnia Disorder
(Thomson Reuters ONE) -
Consistent Improvements Observed With Selective Orexin-2 Receptor Antagonist in
Multiple Parameters of Sleep Induction and Maintenance
WALTHAM, Mass., Jan. 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 favorable top line results from a Phase 2A clinical trial in insomnia
disorder with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist
under joint development with Janssen Pharmaceutica NV.
"These findings were generated with our selective orexin-2 receptor antagonist,
MIN-202, which is designed to physiologically regulate biological rhythm and
control of the overactive wake drive," said Dr. Remy Luthringer, president and
chief executive officer of Minerva. "The data indicate that MIN-202 may
accelerate sleep induction, restore sleep duration and preserve key phases of
sleep, thus enabling restorative sleep."
Patients treated with MIN-202 in the Phase 2A trial were observed to have
statistically significant improvements in key sleep parameters, compared to
patients treated with placebo. These parameters include sleep efficiency as
measured by objective polysomnography, the primary endpoint of the trial, for
which a positive efficacy signal was detected for 40 milligrams MIN-202 versus
placebo (p<0.001). Additional significant positive efficacy signals were
observed for key secondary parameters, including latency to persistent sleep,
wake after sleep onset, and total sleep time.
No serious adverse events were observed in this trial, and preliminary data
indicate that MIN-202 was well tolerated by patients. The most common treatment-
emergent adverse events associated with exposure to MIN-202 during the double-
blind phase of the study were somnolence and abnormal dreams.
The trial was conducted at clinical sites in the U.S. and Europe. Complete
results are planned for peer-reviewed presentation in the future.
The Phase 2A trial was a randomized, two way, cross-over, placebo-controlled
double-blind study to evaluate the effect of MIN-202 on sleep and daytime
functioning in 28 patients with insomnia disorder without psychiatric co-
morbidity. Patients were given MIN-202 or placebo in a cross-over design for
treatment periods of five days, separated by a washout period.
In addition to this trial, a Phase 1B trial with MIN-202 is ongoing in patients
suffering from major depressive disorder (MDD). In this trial, MIN-202 is co-
administered with an antidepressant compound. Enrollment in this trial has been
completed, and top line data are expected in the first quarter of 2016.
Minerva entered into a co-development and license agreement with Janssen in
February, 2014 covering MIN-202 and any 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
2B development for schizophrenia; MIN-202 (JNJ-42847922), in Phase 2A and Phase
1B development for insomnia and adjunctive treatment of MDD, respectively; MIN-
117, in Phase 2A 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 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 2A 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 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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via GlobeNewswire
[HUG#1977710]
Datum: 11.01.2016 - 14:30 Uhr
Sprache: Deutsch
News-ID 443417
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contact information:
Town:
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