Oral presentation highlights specific
improvements in negative symptoms and cognition observed in
schizophrenic patients treated with MIN-101 in Phase IIB
trial
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 presentations at the 55th Annual Meeting of the American
College of Neuropsychopharmacology (ACNP), December 4-8,
2016. Conclusions from these data analyses are summarized
below. The posters will be available following the completion
of the last of these presentations at the ACNP meeting at
http://ir.minervaneurosciences.com/events.cfm.
“The presentations of data from the Phase IIB trial with MIN-101
at ACNP demonstrate broad internal consistency across multiple
endpoints, supporting the direct effect of this compound in
treating negative symptoms in schizophrenia,” said Dr. Remy
Luthringer, president and chief executive officer of Minerva.
“Beyond the significant improvement on negative symptoms observed
in the core 12-week double blind phase of this trial, which was
followed by continuous improvement experienced by patients over an
additional 24-week extension phase, data presented at ACNP show the
potential of treatment with MIN-101 in improving general
psychopathology, cognition and sleep, as well as its marked impact
on younger patients.”
1. Abstract title: “Efficacy and Safety of MIN-101: A New Drug
for the Treatment of Negative Symptoms in Schizophrenia” (Hot
Topics oral presentation session and Poster Session I, Poster Board
M218)
Data from the Phase IIB trial (top line results from which were
first announced in May 2016) demonstrated a statistically
significant improvement in negative symptoms as measured by both
the pentagonal structure model of the Positive and Negative Symptom
scale and the classic PANSS three factors negative symptoms
subscale for both doses tested, 32 milligrams (mg) and 64 mg.
The statistically significant superiority of MIN-101 over
placebo was also observed on most secondary outcomes such as the
PANSS total score, Clinical Global Impression of Improvement
(CGI-I), Clinical Global Impression of Severity (CGI-S), Brief
Negative Symptoms Scale (BNSS) total score, Personal and Social
Performance (PSP) total score, and Calgary Depression Scale for
Schizophrenia (CDSS).
The direct effect of MIN-101 on negative symptoms (rather than
an indirect effect secondary to improvements in other symptoms) was
underscored by the observed stability in positive symptoms, the
absence of extra-pyramidal symptoms (EPS) and the persistence of
this specific effect even after controlling for improvements in
depressive symptoms. Researchers noted that since phenomena
similar to negative symptoms are manifest in many psychiatric
disorders and in brain degenerative disorders such as Azheimer’s
disease and Parkinson’s disease, future trials with MIN-101 could
be designed to explore its potential benefit in these patient
populations.
In post-hoc analysis, improvement in negative symptoms was shown
to be greatest among younger patients, especially in the cohort of
patients under 33 years of age. This finding supports the
potential therapeutic intervention with MIN-101 in younger patients
with schizophrenia who are beginning to manifest these
symptoms. It is also consistent with research showing that
chronic pharmacotherapeutic intervention in schizophrenia, which
includes atypical antipsychotics to treat acute positive symptoms,
becomes less effective as patients age and suffer long-term
consequences of the disease and side effects of current treatment
options.
With respect to safety and tolerability, no weight gain or
clinically significant changes from baseline in vital signs,
prolactin, routine laboratory values and EPS measurements were
observed. As previously announced, two patients out of 162
who received MIN-101 in the core phase of the trial were
discontinued based upon discontinuation criteria related to QTcF
prolongation; both of these patients received the higher dose (64
mg). In the extension phase of the trial, no additional patients
were discontinued.
2. Abstract title: “Effect of MIN-101 on Cognition in
Schizophrenia Patients With Predominant Negative Symptoms: A
12-Week Randomized, Double Blind, Placebo-Controlled Trial” (Poster
Session II, Poster Board T167)
Results from the Phase IIB, double-blind, randomized,
placebo-controlled study suggest a benefit of treatment with
MIN-101 32 mg in improving cognitive function in schizophrenia
patients with predominant negative symptoms. Cognitive
function was evaluated using the Brief Assessment of Cognition in
Schizophrenia (BACS) scale, and data analyses demonstrated
statistically significant differences in the BACS scale between
patients treated with MIN-101 at the 32 mg dose and those who
received placebo. Cognitive dysfunction, a core feature of
schizophrenia, affects up to 75 percent of patients and is viewed
as a good predictor of functional outcome.
3. Abstract title: “MIN-101 Improves Sleep in Patients Suffering
From Schizophrenia: A Randomized, Placebo-Controlled, Double Blind
Study” (Poster Session III, Poster Board W192)
Results from a Phase IIA, double-blind, randomized,
placebo-controlled study showed that treatment with MIN-101 as
monotherapy was associated with significantly improved sleep
induction and normalized slow wave sleep (SWS) ultradian
distribution during the night, which are two key sleep parameters
that are disturbed in schizophrenia. Such disturbances of
sleep architecture and continuity may be associated with memory
consolidation, which is impaired in schizophrenia. These
effects on sleep parameters may help to improve the overall
symptomatology observed in patients suffering from schizophrenia
and treated with MIN-101.
4. Abstract title: “A Randomized, Double-Blind, Parallel-Group,
Placebo- and Active-Controlled Study to Evaluate the Efficacy and
Safety of MIN-117 in Patients With Major Depressive Disorder”
(Poster Session II, Poster Board T132)
Results from a Phase IIA clinical trial demonstrated the
dose-dependent superiority of MIN-117 over placebo in reducing
symptoms of depression as measured by the Montgomery-Asberg
Depression Rating Scale (MADRS). Twenty-four percent of
patients treated with MIN-117 were observed to achieve remission as
prospectively defined. In addition, MIN-117 was observed to
preserve sleep continuity and architecture and therefore is not
expected to have detrimental effects on rapid eye movement (REM)
sleep distribution and duration. MIN-117 also demonstrated a
favorable tolerability profile, and the incidence and types of side
effects did not differ significantly from placebo. Treatment
with MIN-117 was not associated with cognitive impairment, sexual
dysfunction, suicidal ideation or weight gain.
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.
MIN-117
MIN-117 is an antidepressant drug candidate with a
differentiated mechanism of action targeting adrenergic alpha 1a,
alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine
transporters.
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 has completed a Phase IIb clinical trial for schizophrenia;
MIN-117, which has completed a Phase IIa clinical trial development
for MDD; MIN-202 (JNJ-42847922), which has 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 and MIN-117; the
clinical and therapeutic potential of MIN-101 and MIN-117; our
ability to successfully develop and commercialize MIN-101 and
MIN-117; 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 and MIN-117 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 and MIN-117, if any,
will be consistent with the results of past clinical trials;
whether MIN-101 and MIN-117 will be successfully marketed if
approved; whether our therapeutic product discovery and development
efforts with MIN-101 and MIN-117 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
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Apr 2023 to Apr 2024