American Journal of Psychiatry Publishes Minerva Neurosciences’ MIN-101 Phase 2b Trial Results for Treatment of Negative Sy...
July 31 2017 - 08:30AM
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.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
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