Oral
presentation highlights specific improvements in negative symptoms
and cognition observed in schizophrenic patients treated with
MIN-101 in Phase IIB trial
Data also
presented from Phase IIA trials with MIN-101 and
MIN-117
WALTHAM, Mass., Dec. 05, 2016 (GLOBE NEWSWIRE) --
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 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.
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.