Pivotal Phase 3
trial design to include monotherapy administration of MIN-101 and
primary endpoint of improvement in negative symptoms of
schizophrenia
Planned initiation
of MIN-101 Phase 3 development in second half of 2017
WALTHAM, Mass., May 15, 2017 (GLOBE NEWSWIRE) --
Following a recent "end-of-Phase 2" meeting with the U.S. Food and
Drug Administration (FDA), 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 its plans to initiate Phase 3
development of MIN-101, a drug targeting negative symptoms in
schizophrenia patients. A pivotal Phase 3 trial with MIN-101
is expected to be initiated in the second half of 2017.
The Phase 3 trial design will be a 12-week,
double-blind, randomized, placebo-controlled, monotherapy study
testing two doses of MIN-101 in patients with negative symptoms and
a diagnosis of schizophrenia. To be eligible for this study,
patients will be required to have stable negative and positive
symptoms over several months prior to enrollment, with a specified
minimum threshold baseline score on the Positive and Negative
Syndrome Scale (PANSS) negative sub-scale.
After the double-blind phase, patients may enter a
36-week open label extension phase in which all patients will
receive active treatment. This multi-center, international trial is
expected to enroll approximately 500 patients at approximately 60
clinical sites across the U.S. and Europe.
The primary endpoint will be improvement in
negative symptoms at 12 weeks as measured by the PANSS Marder
negative factor score, a widely recognized instrument for
quantifying severity of negative symptoms. Secondary
efficacy endpoints will include the Clinical Global Impression of
Severity (CGI-S) scale and Personal and Social Performance (PSP)
total score. The overall design of the planned Phase 3 trial is
similar to the Phase 2b trial completed in 2016, in which
improvement was observed in schizophrenic patients with negative
symptoms treated with MIN-101 compared to placebo.
The Company shared pre-clinical and clinical
efficacy and safety data at the FDA meeting, and safety and
tolerability of MIN-101 will continue to be assessed during the
duration of the Phase 3 trial, including cardiac function via
electrocardiograms (ECGs). Discontinuation criteria based on
PANSS and cardiac electrophysiological criteria will be
incorporated into the study protocol.
"Minerva is finalizing its plan for the Phase 3
development of MIN-101, an innovative investigational treatment for
schizophrenia, following our recent meeting with the FDA," said Dr.
Remy Luthringer, president and chief executive officer of
Minerva. "Our discussion with the agency has helped to
confirm our Phase 3 trial design, which is similar to our previous
Phase 2b trial design. We believe that positive data from the
Phase 3 trial, along with the positive data from the Phase 2b
trial, may form the basis for the future submission of a New Drug
Application for MIN-101 to the FDA."
"The constructive feedback from the agency
supports the further development of MIN-101 for schizophrenia,"
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. "Negative
symptoms currently continue to represent a significant unmet need
and contribute substantially to poor quality of life and functional
outcomes for the large worldwide population of patients with this
disease."
Updates and further details regarding the Phase 3
trial, including anticipated timing of recruitment, participating
centers and investigators will be provided later this year and
posted on www.clinicaltrials.gov.
About schizophrenia and the
impact of negative symptoms
Schizophrenia remains among the top ten disabling
conditions worldwide for young adults and affects more than 21
million people worldwide. According to Datamonitor, an
independent market research firm, in 2016 approximately
3.3 million people suffered from schizophrenia in the United
States, Japan and the five major European Union markets of France,
Germany, Italy, Spain and the United Kingdom.
Although positive psychotic symptoms are
characteristic of schizophrenia, negative symptoms constitute one
of the main sources of burden of illness, represent an important
treatment target and are a major cause of the poor vocational and
social capabilities of these patients. These symptoms, which
include a-motivation, avolition, lack of initiative, and restricted
personal interaction, are associated with poor psychosocial
functioning.
In the majority of schizophrenia patients, acute
positive symptoms remit due to treatment with antipsychotics
(dopamine-blocking drugs) or spontaneously. Antipsychotic drugs
also reduce the risk for recurrence of psychosis. However, many
patients maintain remission of psychosis without antipsychotic
dopamine blocking drugs. Nevertheless, they continue to
suffer negative symptoms, for which no FDA-approved treatments are
specifically indicated.
About MIN-101
MIN-101 is a drug candidate with equipotent
affinities for sigma 2 and 5-hydroxytryptamine-2A
(5-HT2A) and lower
affinity at alpha1-adrenergic receptors. MIN-101 has no direct
dopaminergic post-synaptic blocking effects, known to be involved
in some side effects like extrapyramidal symptoms, sedation,
prolactin increases and weight gain.
The Phase 2b trial with MIN-101, announced in 2016
and presented at the annual meeting of the American College of
Neuropsychopharmacology, met its primary endpoint of statistically
significant improvement in negative symptoms as measured by the
PANSS pentagonal structure model and in the higher dose showed
statistically significant benefit in multiple secondary endpoints
that included general psychopathology.
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-117, in clinical
development for major depressive disorder (MDD); MIN-202
(JNJ-42847922), in clinical development for insomnia and 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 potential for a single
Phase 3 trial with supportive Phase 2b results to support the basis
for an NDA; 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; 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 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
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