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
data from the 24-week open-label extension of its 12-week,
randomized, double-blind, placebo-controlled Phase IIb clinical
trial of MIN-101 as monotherapy in patients with negative symptoms
of schizophrenia. Data from the 12-week core phase of this trial
were reported in May of this year.
Graphic representations of the data summarized below are
available at http://ir.minervaneurosciences.com/events.cfm and
contained in the Current Report on Form 8-K filed by Minerva on
October 26, 2016.
“Data from the extension phase demonstrate a further and
continuous improvement in negative symptoms in patients with
schizophrenia, as measured by the negative symptom subscales of the
Positive and Negative Syndrome Scale (PANSS),” said Dr. Remy
Luthringer, president and chief executive officer of Minerva. “The
longer patients were on monotherapy with MIN-101, the greater
improvement they were observed to experience in their negative
symptoms during the entire extension period, without evidence of
reaching a plateau. We believe that such continuous improvement in
symptoms over a nine month period in this patient population is
unprecedented.
“The data also provide an extended safety profile for MIN-101
consistent with that observed during the core double-blind phase of
the trial,” said Dr. Luthringer. “MIN-101 was reported to be
well tolerated at both doses over the entire 36-week duration of
the study by schizophrenic patients. In addition, positive
symptoms were observed to remain stable through the extension
period as measured by the PANSS positive symptom subscale score.
Improvements in overall schizophrenic psychopathology were also
observed, as measured by the PANSS general psychopathology subscale
and the total PANSS score.
“We believe these exciting data point the way toward pivotal
testing of MIN-101 as a novel, differentiated treatment for the
large worldwide population of patients with schizophrenia for whom
negative symptoms contribute substantially to poor quality of life
and functional outcomes,” said Dr. Luthringer.
Results announced earlier this year from the double-blind,
placebo-controlled 12-week core phase of the trial showed that it
met its primary endpoint of statistically significant improvement
in negative symptoms as measured by the PANSS pentagonal structure
model (PSM), and showed statistically significant benefit in
multiple secondary endpoints that included general psychopathology
and cognition.
Patients who completed the core phase were provided the
opportunity to enter into a 24-week, open-label extension
phase. During the extension phase, all patients received
either 32 milligrams (mg) or 64 mg of MIN-101. Patients
who received placebo in the core phase were randomized to one of
these two doses at the beginning of the extension phase. Data
generated during the extension period were intended to provide
longer term supportive evidence of efficacy and to complement the
statistically significant results obtained during the core
phase.
One hundred forty-two patients from the treatment and placebo
groups in the core phase entered the extension phase, with 88
patients completing the extension. Seventy patients
received 32 mg and 72 patients received 64 mg during the
extension.
Negative symptoms, assessed based on the PANSS PSM, were
observed to continue to improve during the extension phase, as
shown by a reduction from the study start for the 32 and 64
mg-treated groups of 5.5 points and 4.9 points, respectively, and
by a reduction of 5.4 points and 5.3 points, respectively, in the
PANSS three factors negative symptoms subscale. Reductions
over time of PANSS negative PSM scores are shown in the attached
graph.
http://www.globenewswire.com/NewsRoom/AttachmentNg/a29ffbc7-ffb5-4dd6-af4e-f042defb88d5
Positive symptoms were observed to remain stable throughout the
study, as measured by PANSS positive symptom scores. This finding
is consistent with the hypothesis that MIN-101 has a direct and
specific effect on negative symptoms.
General psychopathology was observed to improve during the
extension phase for the 32 and 64 mg groups, as shown by reductions
in the PANSS general psychopathology subscale score and total PANSS
score.
MIN-101 was generally reported to be well tolerated through the
entire 36-week period. QTcF, a measurement of cardiac
function, was closely monitored throughout the study, and
discontinuation criteria based on QTcF prolongation were
incorporated in the protocol. As previously announced, two
patients out of 162 who received MIN-101 in the core phase were
discontinued based upon these criteria; both of these patients
received the higher dose (64 mg). In the extension phase no
additional patients were discontinued. The extension data
also confirm that MIN-101 at the doses tested did not have an
effect on extra-pyramidal symptoms (EPS), prolactin or weight
gain.
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.
About Schizophrenia and Negative SymptomsAs
described by the National Institute of Mental Health, schizophrenia
is a chronic and severe disorder that affects how a person thinks,
feels and acts1. In 2015 approximately 3.2 million people
suffered from schizophrenia in the U.S., Japan and the five major
European markets. Schizophrenic patients suffer from
positive, negative and cognitive symptoms. Negative symptoms
are disruptions to normal emotions and behaviors that may signal
social withdrawal. Patients may be socially inhibited, lack
the ability to begin and sustain planned activities, or speak
little even when forced to interact. Negative symptoms
account for a substantial portion of the morbidity associated with
schizophrenia2. They persist chronically throughout an
individual patient’s lifetime and increase with severity over
time.
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,
which recently completed a Phase IIb clinical trial for
schizophrenia; MIN-117, which recently completed a Phase IIa
clinical trial development for MDD; MIN-202 (JNJ-42847922),
which recently completed Phase IIa and Phase Ib clinical trials for
insomnia and MDD, respectively; 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; the clinical
and therapeutic potential of MIN-101; our ability to successfully
develop and commercialize MIN-101; 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 our therapeutic product discovery and development
efforts with MIN-101 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 June 30, 2016, filed with
the Securities and Exchange Commission on August 4,
2016. 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.
1 https://www.nimh.nih.gov/health/publications/schizophrenia-booklet-12-2015/index.shtml
2 Diagnostic and Statistical Manual of Mental Disorders,
Fifth Edition, American Psychiatric Association.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
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