Minerva Neurosciences' Clinical Data Featured at The American College of Neuropsychopharmacology Annual Meeting
(Thomson Reuters ONE) -
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.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via GlobeNewswire
Datum: 05.12.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 510864
Anzahl Zeichen: 12516
contact information:
Town:
Waltham
Kategorie:
Business News
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