Minerva Neurosciences Provides Update on MIN-101 and MIN-117 Clinical Programs
(Thomson Reuters ONE) -
Last patient completes extension phase of Phase IIb trial with MIN-101
Company receives FDA acceptance of Investigational New Drug Application for MIN-
117
WALTHAM, Mass., Sept. 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 recent progress in its clinical programs with MIN-101 for
schizophrenia and with MIN-117 for major depressive disorder (MDD).
MIN-101
The last patient has completed the 24-week open-label extension period of the
Company's Phase IIb clinical trial of MIN-101 in patients with negative symptoms
of schizophrenia. Positive results from the prospective 12-week randomized,
double-blind, placebo-controlled core phase of this trial were announced
previously. These results from the core phase demonstrated statistically
significant improvement of negative symptoms, the primary endpoint of the trial,
in patients treated with both 32 milligrams (mg) and 64 mg daily doses of MIN-
101 compared to placebo. Statistically significant benefit of MIN-101 was also
demonstrated in multiple secondary endpoints.
Approximately 140 patients who completed the core phase of this trial entered
the extension phase, during which all patients received one of the two doses of
MIN-101. Patients who received placebo in the core study were randomized to one
of these doses. As planned, the extension phase of the trial was completed in
the third quarter of 2016, and the Company expects to announce top line results
from this phase in the fourth quarter of 2016. The Company has submitted results
from the core phase of the trial for peer-reviewed publication and presentations
and plans to meet with regulatory authorities in the United States and Europe in
preparation for Phase 3 testing of MIN-101, which is expected to begin in 2017.
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
The U.S. Food and Drug Administration (FDA) has accepted the Company's
Investigational New Drug (IND) application to begin clinical testing of MIN-117
in the United States. This acceptance follows positive results from a
randomized, double-blind, placebo- and positive-controlled Phase IIa clinical
trial in MDD with MIN-117 in Europe announced earlier this year. Data from the
study demonstrated the dose-dependent superiority of MIN-117 over placebo in
reducing symptoms of depression and anxiety.
FDA acceptance of the IND for MIN-117 allows the Company to begin clinical
trials with this compound in the U.S., building upon the results from the
European trial. Planning is underway for these trials, which are expected to
begin in 2017.
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
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 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 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.
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: 26.09.2016 - 14:30 Uhr
Sprache: Deutsch
News-ID 496981
Anzahl Zeichen: 7713
contact information:
Town:
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Business News
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