Minerva Neurosciences Reports Topline Results From Phase 2b Trial of MIN-117 in Major Depressive Disorder
December 18 2019 - 4:05PM
Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, announced today
the Phase 2b trial of MIN-117 in adult patients suffering from
moderate to severe major depressive disorder (MDD) and presenting
with symptoms of anxious distress failed to meet its primary and
key secondary endpoints.
Neither dose of MIN-117 tested in this trial
showed a statistically significant separation from placebo on the
reduction in the symptoms of MDD over the 6-week treatment period
as measured by the change in the Montgomery–Åsberg Depression
Rating Scale (MADRS). In addition, neither dose showed a
statistically significant separation from placebo on the key
secondary endpoint, reduction of symptoms of anxiety as measured by
Hamilton Anxiety Rating Scale (HAM-A) over the 6-week treatment
period. Patients treated with the 2.5 mg dose experienced an
improvement of 1.6 points compared to placebo at Week 2 (p≤
0.029). No other statistically significant separation from
placebo on HAM-A was observed.
MIN-117 was generally well-tolerated, and the
incidence of patients who reported treatment emergent adverse
events over the duration of 6 weeks of treatment and 2 weeks of
follow-up were 37% for the 2.5 mg, 39% for the 5 mg, and 38% for
placebo. Only headaches were reported at ≥5% in this study at 12%
for both the 2.5 and 5 mg, and 7% for placebo. There were no
deaths, and only 5 patients in total discontinued from the study
due to TEAE (2 for 2.5 mg, 1 for 5 mg, and 2 for placebo).
“We are obviously disappointed with the results
despite the trial having been very well executed,” said Dr. Remy
Luthringer, Executive Chairman and Chief Executive Officer of
Minerva. “We express our sincere appreciation to all of the
patients, the investigators and their staff who participated in
this trial. At present, we have no plans for further clinical
development of the molecule in MDD.”
Conference call
Minerva will hold a conference call and live
audio webcast on December 18, 2019 at 5:00 p.m. Eastern Time.
To participate, please dial (877) 312-5845 for domestic callers or
(765) 507-2618 for international callers and refer to conference ID
number 3296395. 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 this study
(www.clinicaltrials.gov
Identifier NCT03446846)
This study was a 6-week, 3-arm, randomized,
double-blind, placebo-controlled trial to investigate the safety
and efficacy of MIN-117 in adult patients. 360 patients were
randomly assigned to 1 of 3 treatment arms, including placebo, 5.0
mg. MIN-117 or 2.5 mg. MIN-117, in a 2:1:1 ratio. Patients enrolled
in this study were diagnosed with moderate or severe MDD with
anxious distress and without psychotic features. The study design
had 3 phases: a screening phase of up to 3 weeks (including
washout), a 6-week double-blind treatment phase, and a post-study
follow-up visit. 40 sites in the U.S. and Europe participated
in the trial.
The primary efficacy endpoint was the change in
MADRS total score from baseline (the start of double-blind
treatment) to the end of the double-blind treatment period (week
6). The primary comparisons were between each MIN-117 dose group
and the placebo group. Secondary efficacy evaluations include the
HAM-A, CGI-S, and CGI-I, as well as safety over six weeks of
treatment.
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); 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 and the further clinical
development of MIN-117. 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 or seltorexant 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 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.
William B. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
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