Additional Data Analyses From Phase IIb Trial of MIN-101 in Schizophrenia Underscore Benefit in Multiple Measurements of Cogn...
January 20 2017 - 8:30AM
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
the results of additional data analyses related to cognitive
function from 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 this trial were reported in May 2016, and data from the
24-week open-label extension period of this trial were reported in
October 2016.
“Cognitive impairment is a core feature of schizophrenia,
affects up to 75 percent of the patient population and is a
predictor of poor quality of life and functional status in patients
with this disease,” said Dr. Remy Luthringer, president and chief
executive officer of Minerva. “We have recently completed
additional analyses from our Phase IIb trial with MIN-101 that show
significant improvements in several sub-tests of cognitive
functioning, including motor tests and verbal fluency in patients
with schizophrenia. Deficits in these capabilities are
associated with poor interpersonal and real-world functioning for
these patients. We believe these latest findings hold promise
for further clinical research in the improvement of cognitive
function and drug development in schizophrenia.”
Cognitive function in this trial was evaluated using the Brief
Assessment of Cognition in Schizophrenia (BACS) scale. This
scale was developed specifically to assess cognitive impairment in
patients with schizophrenia. Key data findings include the
following:
|
|
|
P-value |
|
Effect size |
|
|
|
32mg |
|
64mg |
|
32mg |
|
64mg |
|
- Motor Function: Token Motor Task |
|
0.0306 |
|
0.0493 |
|
0.42 |
|
0.38 |
|
- Motor
Function: Symbol Coding Task |
|
0.6310 |
|
0.0781 |
|
0.09 |
|
0.33 |
|
- Verbal
Fluency: Semantic Fluency |
|
0.0299 |
|
0.1838 |
|
0.42 |
|
0.25 |
|
- Verbal
Fluency: Letter Fluency |
|
0.0328 |
|
0.0878 |
|
0.41 |
|
0.32 |
|
- Total
Verbal Fluency |
|
0.0076 |
|
0.0554 |
|
0.51 |
|
0.36 |
|
- Verbal
Memory |
|
0.1544 |
|
0.3158 |
|
0.27 |
|
0.19 |
|
-
Executive Function: Tower of London |
|
0.3988 |
|
0.1952 |
|
0.16 |
|
0.25 |
|
BACS
cognition assessment (Composite T Score) |
|
0.2737 |
|
0.8253 |
|
0.21 |
|
-0.04 |
|
|
Top line results previously announced from the double-blind,
placebo-controlled 12-week core phase of the Phase IIb trial with
MIN-101 showed that it met its primary endpoint of statistically
significant improvement in negative symptoms as measured by the
PANSS pentagonal structure model (PSM) and also showed
statistically significant benefit in multiple secondary endpoints
that included general psychopathology. Data from the
extension phase of this trial showed continuous improvement in
negative symptoms over a nine month period.
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
As 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. Similar to negative
symptoms, cognitive symptoms may be difficult to recognize and
often are detected only when specific testing is performed.
Cognitive symptoms include: poor “executive functioning,” or the
ability to understand information and use it to make decisions;
trouble focusing or paying attention; problems with “working
memory,” or the ability to use information immediately after
learning it. Poor cognition is related to worse employment
and social outcomes for patients with schizophrenia.
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.
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; 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,
they 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 September 30, 2016, filed with
the Securities and Exchange Commission on November
3, 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.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
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