Minerva Neurosciences, Inc. : Minerva Neurosciences Announces Update on MIN-101 Clinical Development Program
(Thomson Reuters ONE) -
WALTHAM, Mass., Dec. 29, 2015 (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 that the U.S. Food and Drug Administration (FDA) has accepted the
Company's Investigational New Drug (IND) application for MIN-101, a first-in-
class 5-HT2a and sigma2 antagonist in clinical development for the treatment of
schizophrenia.
In addition, the Company announced the completion of the enrollment of a total
of 244 patients in a randomized, placebo-controlled double-blind European Phase
IIb clinical trial of MIN-101. The primary objective of this trial is to
evaluate the efficacy of MIN-101 compared to placebo in improving the negative
symptoms of schizophrenic patients. Additional objectives include the
assessment of cognitive symptoms and overall symptomatology of the disease
following treatment with MIN-101. Topline results from the core 12-week
treatment evaluation period are expected in the second quarter of 2016.
"Acceptance of the IND for MIN-101 is an important step toward the initiation of
advanced-stage clinical testing of this compound in the U.S. following the
results of our ongoing Phase IIb trial in Europe," said Remy Luthringer,
president and chief executive officer of Minerva. "We will be continuing our
dialogue with the FDA as part of our overall planning for late-stage clinical
testing in the U.S."
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 the adjunctive treatment of major
depressive disorder (MDD), respectively; MIN-117, in 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-101; the clinical and therapeutic potential of MIN-101; our
ability to successfully develop and commercialize MIN-101; 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 MIN-101 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-101 will be
successfully marketed if approved; whether our therapeutic product discovery and
development efforts with MIN-101 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, 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#1975988]
Datum: 29.12.2015 - 22:01 Uhr
Sprache: Deutsch
News-ID 441845
Anzahl Zeichen: 5654
contact information:
Town:
Waltham
Kategorie:
Business News
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