Minerva Neurosciences Announces Completion of Patient Screening in Phase 3 Trial of Roluperidone for the Treatment of Negativ...
January 06 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 screening in its ongoing Phase 3 trial with roluperidone to
treat negative symptoms in schizophrenia.
A total of 857 patients have been screened, and the enrollment
of at least 501 patients is expected to be completed before the end
of January 2020. Top-line results from the 12-week, double-blind
portion of the trial are expected in the second quarter of
2020.
This trial is a multicenter, 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 Positive and Negative Syndrome Scale Marder
negative symptoms factor score, 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 to placebo. The core 12-week 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.
“We are pleased to have achieved the important milestone of
having completed patient screening in the Phase 3 trial with
roluperidone,” said Dr. Remy Luthringer, Executive Chairman and
Chief Executive Officer of Minerva. “Our consistent
objectives throughout the trial have been to ensure the highest
quality of patient selection and the rigorous evaluation of the
symptoms of schizophrenia, including negative symptoms. We
look forward to randomizing the last patient in January, 2020 and
to having top-line results in the second quarter of 2020.”
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 Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
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