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
sigma2 and
5HT2A 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.