Minerva Neurosciences Announces Completion of Patient Enrollment in Phase 3 Trial of Roluperidone for the Treatment of Negati...
February 05 2020 - 8:00AM
Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
addressing high unmet medical needs in the treatment of central
nervous system (CNS) disorders, today announced the completion of
patient randomization in the pivotal, Phase 3 multicenter trial of
roluperidone, its lead product, for the treatment of negative
symptoms in schizophrenia.
A total of 515 patients have been randomized in this trial,
compared to the original goal of 501 patients. The trial, which is
being conducted at clinical sites in the U.S. and Europe, is a
randomized, double-blind, parallel-group, placebo-controlled,
12-week study to evaluate the efficacy and safety of 32 milligram
(mg) and 64 mg doses of roluperidone as measured by the Marder
negative symptoms factor score of the Positive and Negative
Syndrome Scale, the primary endpoint. Secondary endpoints
include the Personal and Social Performance Scale and Clinical
Global Impression of Severity. Patients are being randomized
1:1:1 to the 32 mg and 64 mg doses of roluperidone and
placebo. The core 12-week double-blind phase of the trial is
followed by a 40-week, open-label extension period during which
patients on the drug continue receiving their original dose and
patients on placebo receive one of the two doses of
roluperidone. Top-line results from the 12-week, double-blind
portion of the trial are expected in the second quarter of
2020.
“The completion of patient enrollment marks a major milestone in
the Phase 3 trial with roluperidone,” said Dr. Remy Luthringer,
Executive Chairman and Chief Executive Officer of Minerva.
“We believe the data from this trial have the potential to lead to
a significant new treatment option for schizophrenia, as no
pharmacological agent is approved to treat negative symptoms, which
is the single greatest unmet need for patients with this disease,
their families and their physicians.”
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of a portfolio of product candidates to treat CNS
diseases. Minerva’s proprietary compounds include:
roluperidone (MIN-101), in clinical development for schizophrenia;
seltorexant (MIN-202 or 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
scope of future clinical trials and results of clinical trials with
roluperidone (MIN-101); the clinical and therapeutic potential of
this compound; the timing and outcomes of future interactions with
U.S. and foreign regulatory bodies; our ability to successfully
develop and commercialize our therapeutic products; 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 roluperidone 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 any of our therapeutic products
will be successfully marketed if approved; whether any of our
therapeutic product discovery and development efforts will be
successful; 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, 2019, filed
with the Securities and Exchange Commission on November 4,
2019. 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. BoniVP, Investor RelationsCorp. CommunicationsMinerva
Neurosciences, Inc.(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
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