Minerva Neurosciences Announces Update for Three Clinical Trials
October 01 2019 - 7:30AM
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 an
update on three clinical-stage programs with roluperidone
(MIN-101), seltorexant (MIN-202) and MIN-117. The Company
will hold a conference call at 8:30 a.m. today to discuss these
programs (see dial-in information below).
- Roluperidone: A total
of 384 patients of a target total number of 501 patients have been
enrolled into the ongoing Phase 3 trial with roluperidone to treat
negative symptoms in schizophrenia, and there are currently 33
patients in screening. Due to a cyber-attack on one of the
Company’s external contractors that resulted in a disruption to
patient recruitment in the study, the Company now expects to
complete enrollment at approximately year-end and anticipates
top-line results from the 12-week, double-blind portion of the
study to be available in the first half 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 mg and 64 mg doses of roluperidone as measured by the
Positive and Negative Syndrome Scale (PANSS) Marder negative
symptoms factor score. The core 12-week study 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.
- MIN-117: Patient screening has been completed
in the Phase 2b trial of MIN-117 in moderate to severe major
depressive disorder (MDD). Top-line results are expected in
the fourth quarter of 2019.
- Seltorexant (MDD2002 Phase 2 trial): In
this clinical trial, long-term (24-week/6-month), flexibly dosed
seltorexant (20 mg or 40 mg) was compared to flexibly dosed
quetiapine XR (150 mg or 300 mg) for adjunctive treatment of
patients suffering from Major Depressive Disorder (MDD). 102
patients with MDD not responding adequately to SSRIs and SNRIs were
enrolled. The primary endpoint was discontinuation of therapy, due
to all causes, over 6 months. Mood improvement, measured
using the Montgomery Asberg Depression Rating Scale (MADRS), and
safety and tolerability were also evaluated. This exploratory
trial was intended primarily to generate data to assist with the
planning of Phase 3 studies and was not powered to detect
statistical significance. Quetiapine XR was used as a
comparator, because it is the only medication approved for the
adjunctive treatment of MDD in both the U.S. and Europe.
Seltorexant showed a
quantitative advantage in the number of discontinuations due to all
causes, with 41% discontinuation in the seltorexant arm versus 47%
in the quetiapine XR arm. As expected, there was not a statistical
separation between the two treatment arms.Mood improvement as
measured by MADRS total score showed patients treated with
seltorexant 20 mg dose experienced a greater improvement at week 24
(-22.7 points), compared to those treated with seltorexant 40 mg
dose (-7.9 points), quetiapine 150 mg dose (-17.0 points) and
quetiapine 300 mg dose (-14.8 points). As was shown in
previous trials of seltorexant in MDD, a greater improvement in
MADRS total score was observed in patients with sleep disturbance
(Insomnia Severity Index ≥15) who received the 20 mg seltorexant
dose. In these patients with insomnia, the improvements
observed were -26.5 for the 20 mg seltorexant dose, -7.0 for the 40
mg seltorexant dose, -18.2 for the 150 mg quetiapine dose and -13.8
for the 300 mg quetiapine dose.
The overall safety profile of the seltorexant groups
was favorable compared to quetiapine, consistent with prior
seltorexant studies, and extended to longer-term exposure over 6
months. Patients receiving seltorexant also experienced fewer
potentially treatment-related discontinuations than did patients
receiving quetiapine (29.4% vs 47.1%).The results of this study,
taken with the results of the two previous studies (MDD2001 in MDD
patients and ISM2005 in patients with insomnia), will help to
define a Phase 3 clinical development program for seltorexant that
potentially will encompass both MDD and insomnia.
Conference Call Information:
Minerva Neurosciences will hold a conference call and live audio
webcast on October 1, 2019 at 8:30 a.m. Eastern Time to discuss the
results of this trial. To participate, please dial (877)
312-5845 (domestic) or (765) 507-2618 (international) and refer to
conference ID 7235727 To access the webcast, please go to
https://edge.media-server.com/mmc/p/xazdqtav..
The live webcast can also be accessed under “Events and
Presentations” in the Investors and Media section of Minerva’s
website at ir.minervaneurosciences.com. The archived webcast
will be available on the website beginning approximately two hours
after the event for 90 days.
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 Major Depressive Disorder (MDD); MIN-117, in clinical
development for 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 http://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, seltorexant and MIN-117; the clinical and therapeutic
potential of these compounds; 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, seltorexant 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 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 June 30, 2019, filed with
the Securities and Exchange Commission on August 5,
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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