American Journal of Psychiatry Publishes Minerva Neurosciences' MIN-101 Phase 2b Trial Results for Treatment of Negative Symptoms in Schizophrenia
(Thomson Reuters ONE) -
WALTHAM, Mass., July 31, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc.
(NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the
development of therapies to treat central nervous system disorders, today
announced that the American Journal of Psychiatry has published online results
from its previously reported Phase 2b clinical trial of MIN-101. MIN-101 is a
novel compound with affinities for sigma(2) and 5HT(2A) receptors but no direct
activity on dopamine receptors. In this regard, MIN-101 differs from drugs
currently indicated for schizophrenia, all of which directly interfere with
dopamine neurotransmission by antagonizing dopamine receptors.
The manuscript, entitled "Efficacy and Safety of MIN-101: A 12-Week Randomized,
Double-Blind, Placebo-Controlled Trial of New Drug in Development for the
Treatment of Negative Symptoms in Schizophrenia," and be found online
at http://www.medical-reprints.com/US-MN-AJP-Davidson.
The key finding from the publication is that MIN-101 achieved its primary
outcome in the trial, demonstrating statistically significant superiority over
placebo in improving negative symptoms in schizophrenia patients as measured by
the pentagonal negative symptoms cluster of the Positive and Negative Syndrome
Scale (PANSS). The improvement in negative symptoms was shown for both doses
tested: 32 milligrams (mg): p = 0.024 effect size = 0.45, and 64 mg: p = 0.004
effect size = 0.57.
Supporting these findings were similar and concomitant improvements on several
secondary outcome measures, including PANSS cluster analyses of negative
symptoms, the PANSS total score, the Clinical Global Impression (CGI) and the
Brief Negative Symptom Scale (BNSS). Psychosis measured by the PANSS Positive
symptoms subscale remained stable during the trial, suggesting that the
improvement in negative symptoms associated with MIN-101 was specific and not a
pseudo-effect secondary to improvements in psychosis.
MIN-101 also demonstrated good tolerability, with no weight gain or other
metabolic abnormalities, no clinically significant changes in vital signs,
routine laboratory values, sedation and extra-pyramidal symptoms (EPS). The
lack of observed adverse effects associated with MIN-101 treatment as compared
to placebo helped to preserve the blinding of the trial, further supporting the
validity and specificity of the improvement observed in negative symptoms.
"Negative symptoms, which tend to persist even after psychosis improves, are the
main impediment to social reintegration of schizophrenia patients," said Dr.
Philip D. Harvey, Leonard M. Miller Professor of Psychiatry and Director of the
Division of Psychology at the University of Miami Miller School of Medicine and
an expert in the rehabilitation of schizophrenia patients. "No drugs in the U.S.
are currently indicated for negative symptoms in schizophrenia, and a drug with
specific effects on negative symptoms has a real chance to improve the day-to-
day social and vocational functioning of patients affected by this disease."
"The findings published in the American Journal of Psychiatry are noteworthy in
that MIN-101 was shown to improve negative symptoms without blocking dopamine
receptors, unlike other drugs indicated for schizophrenia," said Dr. Harvey.
"As such, it may be better tolerated by patients and may improve drug
adherence, which is particularly problematic in treating schizophrenia." Dr.
Harvey was not involved in the design or the conduct of the Phase 2b trial with
MIN-101.
"The publication of these data by a prestigious journal like the American
Journal of Psychiatry is important for Minerva because it reflects a peer-
reviewed recognition by the scientific and medical community of a new and
innovative potential approach to alleviating the most debilitating symptoms in
patients suffering from schizophrenia," said Dr. Remy Luthringer, president and
chief executive officer of Minerva.
Following a recent "end-of-Phase 2" meeting with the U.S. Food and Drug
Administration (FDA), Minerva expects to initiate a pivotal Phase 3 trial with
MIN-101 to treat negative symptoms in schizophrenia in the second half of 2017.
About the American Journal of Psychiatry
The American Journal of Psychiatry is the official journal of the American
Psychiatric Association (APA), the oldest medical association in the country,
founded in 1844. It is published monthly and is focused on a broad spectrum of
issues and advances in the diagnosis and treatment of mental illness. The APA
is the largest psychiatric association in the world with more than 37,000
physician members specializing in the diagnosis, treatment, prevention and
research of mental illness.
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; MIN-202 (JNJ-42847922), 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-101, including the planned Phase 3 trial of MIN-101, 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 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 the results of future clinical trials of MIN-101, if
any, will be consistent with the results of past clinical trials; whether MIN-
101 will be successfully marketed if approved; whether any of our therapeutic
product discovery and development efforts will be successful; 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 March 31, 2017, filed with the Securities and Exchange Commission on May
4, 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: 31.07.2017 - 14:30 Uhr
Sprache: Deutsch
News-ID 554604
Anzahl Zeichen: 9270
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