Minerva Neurosciences Announces Positive Data From Six-Month Extension of Phase IIb Trial of MIN-101 Monotherapy in Schizophrenia
(Thomson Reuters ONE) -
Data show continuous improvement in negative symptoms, stable positive symptoms
and extended safety profile
WALTHAM, Mass., Oct. 26, 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 from the 24-week open-label extension of 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 the
12-week core phase of this trial were reported in May of this year.
Graphic representations of the data summarized below are available
at http://ir.minervaneurosciences.com/events.cfm and contained in the Current
Report on Form 8-K filed by Minerva on October 26, 2016.
"Data from the extension phase demonstrate a further and continuous improvement
in negative symptoms in patients with schizophrenia, as measured by the negative
symptom subscales of the Positive and Negative Syndrome Scale (PANSS)," said Dr.
Remy Luthringer, president and chief executive officer of Minerva. "The longer
patients were on monotherapy with MIN-101, the greater improvement they were
observed to experience in their negative symptoms during the entire extension
period, without evidence of reaching a plateau. We believe that such continuous
improvement in symptoms over a nine month period in this patient population is
unprecedented.
"The data also provide an extended safety profile for MIN-101 consistent with
that observed during the core double-blind phase of the trial," said Dr.
Luthringer. "MIN-101 was reported to be well tolerated at both doses over the
entire 36-week duration of the study by schizophrenic patients. In addition,
positive symptoms were observed to remain stable through the extension period as
measured by the PANSS positive symptom subscale score. Improvements in overall
schizophrenic psychopathology were also observed, as measured by the PANSS
general psychopathology subscale and the total PANSS score.
"We believe these exciting data point the way toward pivotal testing of MIN-101
as a novel, differentiated treatment for the large worldwide population of
patients with schizophrenia for whom negative symptoms contribute substantially
to poor quality of life and functional outcomes," said Dr. Luthringer.
Results announced earlier this year from the double-blind, placebo-controlled
12-week core phase of the trial showed that it met its primary endpoint of
statistically significant improvement in negative symptoms as measured by the
PANSS pentagonal structure model (PSM), and showed statistically significant
benefit in multiple secondary endpoints that included general psychopathology
and cognition.
Patients who completed the core phase were provided the opportunity to enter
into a 24-week, open-label extension phase. During the extension phase, all
patients received either 32 milligrams (mg) or 64 mg of MIN-101. Patients who
received placebo in the core phase were randomized to one of these two doses at
the beginning of the extension phase. Data generated during the extension
period were intended to provide longer term supportive evidence of efficacy and
to complement the statistically significant results obtained during the core
phase.
One hundred forty-two patients from the treatment and placebo groups in the core
phase entered the extension phase, with 88 patients completing the extension.
Seventy patients received 32 mg and 72 patients received 64 mg during the
extension.
Negative symptoms, assessed based on the PANSS PSM, were observed to continue to
improve during the extension phase, as shown by a reduction from the study start
for the 32 and 64 mg-treated groups of 5.5 points and 4.9 points, respectively,
and by a reduction of 5.4 points and 5.3 points, respectively, in the PANSS
three factors negative symptoms subscale. Reductions over time of PANSS
negative PSM scores are shown in the attached graph.
http://www.globenewswire.com/NewsRoom/AttachmentNg/a29ffbc7-ffb5-4dd6-af4e-
f042defb88d5
Positive symptoms were observed to remain stable throughout the study, as
measured by PANSS positive symptom scores. This finding is consistent with the
hypothesis that MIN-101 has a direct and specific effect on negative symptoms.
General psychopathology was observed to improve during the extension phase for
the 32 and 64 mg groups, as shown by reductions in the PANSS general
psychopathology subscale score and total PANSS score.
MIN-101 was generally reported to be well tolerated through the entire 36-week
period. QTcF, a measurement of cardiac function, was closely monitored
throughout the study, and discontinuation criteria based on QTcF prolongation
were incorporated in the protocol. As previously announced, two patients out of
162 who received MIN-101 in the core phase were discontinued based upon these
criteria; both of these patients received the higher dose (64 mg). In the
extension phase no additional patients were discontinued. The extension data
also confirm that MIN-101 at the doses tested did not have an effect on extra-
pyramidal symptoms (EPS), prolactin or weight gain.
About MIN-101
MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5-
hydroxytryptamine-2A (5-HT(2A)) 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.
About Schizophrenia and Negative Symptoms
As described by the National Institute of Mental Health, schizophrenia is a
chronic and severe disorder that affects how a person thinks, feels and
acts(1). 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
schizophrenia(2). They persist chronically throughout an individual patient's
lifetime and increase with severity over time.
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
recently completed a Phase IIb clinical trial for schizophrenia; MIN-117, which
recently completed a Phase IIa clinical trial development for MDD; MIN-202
(JNJ-42847922), which recently 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; 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,
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 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 June 30, 2016, filed with the Securities and Exchange Commission on August
4, 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.
(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.
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: 26.10.2016 - 14:30 Uhr
Sprache: Deutsch
News-ID 502964
Anzahl Zeichen: 11384
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Town:
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