Pivotal Phase 3 trial design to include
monotherapy administration of MIN-101 and primary endpoint of
improvement in negative symptoms of schizophrenia
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 α1-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
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