Minerva Neurosciences Announces Top Line Data From MIN-202 Phase I Clinical Study in Japanese Patients
(Thomson Reuters ONE) -
Treatment With Selective Orexin-2 Receptor Antagonist Observed to be Well
Tolerated
WALTHAM, Mass., Feb. 01, 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 top line results from a Phase I clinical trial conducted in Japan with
MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint
development with Janssen Pharmaceutica NV.
It was observed that single dose morning administration of MIN-202 was well
tolerated at all three dose levels tested, 5 milligrams (mg), 20 mg and 40 mg.
The observed plasma pharmacokinetic features were comparable to those observed
in previous studies carried out in healthy non-Asian study participants. No
clinically relevant safety concerns were observed based on the assessment of
multiple safety endpoints. Somnolence was the most frequently reported adverse
event at the two higher doses, an expected finding as this compound is being
developed as a treatment for patients suffering from insomnia disorder and as
adjunctive treatment to concomitant antidepressant drug therapy in major
depressive disorder (MDD).
"These findings are an important step in the global development of MIN-202,"
said Dr. Remy Luthringer, president and chief executive officer of Minerva.
"They add to the expanding database of study participants treated with this
compound worldwide and support further clinical testing in an important part of
the world."
This trial was a single center, double blind, placebo-controlled randomized
single ascending dose study to investigate the safety, tolerability and
pharmacokinetics of MIN-202 in 24 healthy Japanese adult male study
participants.
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.
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#1982149]
Datum: 01.02.2016 - 14:30 Uhr
Sprache: Deutsch
News-ID 447740
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