Minerva Provides Update on Phase 3 Design and Development Strategy for MIN-101
(Thomson Reuters ONE) -
Advancing a new potential therapeutic paradigm for the treatment of negative
symptoms, a key unmet need in schizophrenia and other brain diseases
Company to host conference call on May 16, 2017 at 10:30 a.m. eastern time
WALTHAM, Mass., May 15, 2017 (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 plans for its Phase 3 and Phase 4 clinical development of MIN-101, a
drug targeting negative symptoms in schizophrenia patients. Following a recent
"end-of-Phase 2" meeting with the U.S. Food and Drug Administration (FDA), the
Company's next step is the planned initiation of a pivotal Phase 3 trial with
MIN-101 in the second half of 2017.
"We are very excited to be taking MIN-101 into a pivotal Phase 3 trial, which
has the potential to identify a new approach to the treatment of schizophrenia
and improve the quality of life for millions of patients," said Dr. Remy
Luthringer, president and chief executive officer of Minerva. "Our development
strategy for MIN-101 is driven by the recognition that, while positive symptoms
are present intermittently and are a hallmark of early schizophrenia, negative
symptoms persist and worsen over the lifetimes of the majority of schizophrenic
patients, severely limiting their social and vocational reintegration over the
longer term. No drugs are currently approved to treat the negative symptoms of
schizophrenia or negative symptoms present in other conditions, including
developmental disorders, affective disorders and neurodegenerative disorders."
Data from the Company's Phase 2b trial with MIN-101 have informed the design of
the Phase 3 trial. Key findings from the Phase 2b trial include observations of
a direct effect on negative symptoms (rather than an indirect or pseudo effect
linked to improvements in other symptoms and/or a different side effect
profile). The data also support the durability of this effect through the
entire 36-week duration of the trial, which included a 12-week double-blind,
placebo-controlled core phase and a 24-week, open-label extension phase. The
specificity of MIN-101's therapeutic effects on negative symptoms was validated
by the stability of positive symptoms observed over the entire duration of
treatment and a side effect profile comparable to placebo, particularly as it
relates to extra-pyramidal symptoms (EPS). The Company believes that the unique
pharmacological profile of MIN-101 (sigma 2 and serotonin 5HT2a receptor
antagonism) and the absence of direct binding to post-synaptic dopamine
receptors may explain its specific effects on negative symptoms.
Key elements of the Phase 2b trial that will be incorporated into the Phase 3
trial include:
* improvement in negative symptoms as the primary endpoint;
* monotherapy administration of MIN-101 and no co-administration with atypical
antipsychotics at any stage in the study;
* recruitment of patients with moderate-to-severe negative symptoms expressed
as a specified minimum threshold baseline score on the Positive and Negative
Syndrome Scale (PANSS) negative sub-scale; and
* a 12-week double-blind, randomized, placebo-controlled core phase followed
by an open-label extension phase.
Two doses of MIN-101 or placebo will be administered during the double-blind
phase of the Phase 3 trial, which will last 12 weeks, followed by an optional
36-week extension phase in which all patients will receive MIN-101.
Approximately 500 patients will be enrolled at approximately 60 clinical sites
across the U.S. and Europe, with a significant number of patients recruited at
U.S. sites. The Company believes that the efficacy data from the Phase 3 trial,
if positive, in addition to the Phase 2b data, may form the basis for the future
submission of a New Drug Application (NDA) for MIN-101 to the FDA. Furthermore,
at the conclusion of the extension period of the Phase 3 trial, the overall
number of patients exposed to MIN-101 since the initiation of its clinical
development is expected to provide sufficient long-term safety data to support
an NDA.
The primary Phase 3 trial endpoint of improvement in negative symptoms at 12
weeks will be measured by the PANSS negative sub-scale score using the Marder
factor, a widely recognized instrument for quantifying severity of negative
symptoms. The Marder negative sub-score is similar to the White negative sub-
score used in the Phase 2b trial. The two factors differ from each other in
that the Marder score has eliminated four items and added one on active social
avoidance (G16 item). The Company is employing the Marder scale because this
item has been shown to be well correlated with patients' overall functional
outcome.
The Company's Phase 3 trial design is intended to replicate the experience of
"real world" clinical practice in schizophrenia. Many patients are dissatisfied
and not well served by continuous antipsychotic treatment as evidenced by poor
compliance with medications. Recent scientific literature points toward the fact
that indefinite antipsychotic maintenance treatment in schizophrenic patients
(provided by post-synaptic blockade of dopamine receptors) may be responsible
for poor long term functional outcomes in addition to well described side
effects, including EPS, weight gain, sedation and prolactin increase. In
summary, the Phase 3 trial will seek to confirm clinically meaningful effects on
patients' negative symptoms and to determine whether patients can stay stable in
terms of positive symptoms without experiencing the adverse effects of
antipsychotics.
Treatment of the positive symptoms of schizophrenia represents a large market
estimated at more than $6.2 billion in 2016. Epidemiological studies suggest
that an estimated 60 percent of schizophrenia patients present with negative
symptoms, which are the basis of poor functional outcome and thus represent a
significant unmet medical need and burden for patients, families and society.
In Phase 4 development, the Company plans to conduct additional trials to expand
the profile of MIN-101. These may potentially include a study comparing the
rate of psychosis relapses in patients treated with MIN-101, standard of care
with antipsychotics or placebo. In addition, the Company may conduct a trial in
adolescents at high risk for schizophrenia who during the prodromal phase
manifest negative symptoms.
While negative symptoms are a core component of schizophrenia and predict poor
functional capacity, they are not specific to that disease but are also
recognized as a hallmark of other diseases. These include neurodegenerative
disorders such as Alzheimer's disease, Parkinson's disease, mood disorders,
schizophrenia spectrum disorders and autism spectrum disorders. The Company
plans to assess these indications as expansion options for MIN-101 in a
development program beyond the planned Phase 3 study in schizophrenia.
Conference call information
The Company will host a conference call and live webcast tomorrow, May 16, 2017
at 10:30 a.m. Eastern Time to discuss its plans for Phase 3 development of MIN-
101 and beyond. The topics outlined above will be addressed. To participate,
please dial 800-263-8506 (domestic) or 719-457-2605 (international) and refer to
conference ID # 1545954. Leading the call will be Dr. Remy Luthringer,
president and chief executive officer of Minerva. Also participating will be
key opinion leaders in the field of schizophrenia, including Dr. Philip Harvey,
Leonard M. Miller Professor of Psychiatry and director of the Division of
Psychology at the University of Miami Miller School of Medicine, and Dr. Brian
Kirkpatrick, chair of the Department of Psychiatry and Behavioral Sciences at
the University of Nevada School of Medicine. Both Dr. Harvey and Dr.
Kirkpatrick are internationally recognized for their work in the field of
schizophrenia and negative symptoms, and they participated in the recent meeting
between the FDA and Minerva as consultants to the Company.
The webcast can be accessed under "Events and Presentations" in the Investors
and Media section of Minerva's website beginning approximately two hours after
the event for 90 days.
About schizophrenia and the impact of negative symptoms
Schizophrenia remains among the top ten disabling conditions worldwide for young
adults and affects more than 21 million people worldwide. According to
Datamonitor, an independent market research firm, in 2016 approximately
3.3 million people suffered from schizophrenia in the United States, Japan and
the five major European Union markets of France, Germany, Italy, Spain and the
United Kingdom.
Although positive psychotic symptoms are characteristic of schizophrenia,
negative symptoms constitute one of the main sources of burden of illness,
represent an important treatment target and are a major cause of the poor
vocational and social capabilities of these patients. These symptoms, which
include a-motivation, avolition, lack of initiative, and restricted personal
interaction, are associated with poor psychosocial functioning.
In the majority of schizophrenia patients, acute positive symptoms remit due to
treatment with antipsychotics (dopamine-blocking drugs) or spontaneously.
Antipsychotic drugs also reduce the risk for recurrence of psychosis. However,
many patients maintain remission of psychosis without antipsychotic dopamine
blocking drugs. Nevertheless, they continue to suffer negative symptoms, for
which no FDA-approved treatments are specifically indicated.
About MIN-101
MIN-101 is a drug candidate with equipotent affinities for sigma2 and 5-
hydroxytryptamine-2A (5-HT2A) and lower affinity at A1-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.
The Phase 2b trial with MIN-101, announced in 2016 and presented at the annual
meeting of the American College of Neuropsychopharmacology, met its primary
endpoint of statistically significant improvement in negative symptoms as
measured by the PANSS pentagonal structure model and in the higher dose showed
statistically significant benefit in multiple secondary endpoints that included
general psychopathology.
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, including the planned Phase 3 trial of MIN-101, the
timing and scope of future clinical trials and results of clinical trials with
this compound; the potential for a single Phase 3 trial with supportive Phase
2b results to support the basis for an NDA; the timing and outcomes of future
interactions with U.S. and foreign regulatory bodies; our ability to
successfully develop and commercialize MIN-101; the sufficiency of our current
cash position to fund our operations; 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 any of our therapeutic product discovery and development efforts 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 March 31, 2017, filed with
the Securities and Exchange Commission on May 4, 2017. 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: 15.05.2017 - 14:15 Uhr
Sprache: Deutsch
News-ID 543913
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Town:
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