Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system disorders, announced today that the
Phase 3 trial of roluperidone to treat negative symptoms in
schizophrenia did not meet its primary (reduction in PANSS Marder
Negative Symptoms Factor Score or NSFS) and key secondary
(improvement in the Personal and Social Performance Scale Total
Score or PSP) endpoints.
Trial parameters and top-line results
In total, 515 patients were enrolled into the trial, and 513
patients received treatment and were included in the safety and
Intent-To-Treat population. The trial was conducted in the USA,
Europe and Israel. There were 172 patients who received placebo,
172 patients who received roluperidone 32 mg, and 171 patients who
received roluperidone 64 mg. Demographic and baseline disease
characteristics were comparable across all treatment arms.
The results for both roluperidone doses versus placebo across
both the primary and the key secondary endpoints to Week 12 were
corrected for multiplicity using the truncated Hochberg
procedure.
The primary objective of the trial was to evaluate the change
from baseline to Week 12 of NSFS with 32 mg and 64 mg doses of
roluperidone compared to placebo in patients diagnosed with
schizophrenia presenting with moderate to severe negative symptoms.
Neither the 32 mg nor 64 mg dose of roluperidone showed a
statistically significant separation from placebo (32 mg:
p ≤0.256, effect size [ES]=0.1; 64 mg: p ≤0.064, ES=0.2).
Furthermore, neither dose showed a statistically significant
separation from placebo on the key secondary endpoint, the change
from baseline to Week 12 in PSP (32 mg: p ≤0.542, ES=0.1;
64 mg: nominal p ≤0.021, ES=0.3).
Although limited inferences can be drawn from this data,
unadjusted statistically significant separations from placebo were
observed in NSFS at Week 4 for both doses (32 mg: nominal
p ≤0.036, ES=0.2; 64 mg: nominal p ≤0.007, ES=0.3), and
at Week 8 for the 64 mg dose (nominal p ≤0.027, ES=0.3), and
the 64 mg dose was statistically significantly different from
placebo as measured by change in PSP at all other assessment
timepoints (Week 4, nominal p ≤0.005, ES=0.3; Week 8: nominal
p ≤0.018, ES=0.3).
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Overall, subgroup analyses by region (USA and rest of the world)
and by age groups were similar.
Roluperidone was generally well tolerated, and the incidences of
patients who reported treatment‑emergent adverse events over the
duration of 12 weeks of treatment were 37% for the 64 mg group, 42%
for the 32 mg group, and 33% for placebo. Only 42 patients
discontinued from the study due to adverse events, 16 (9%) in 64 mg
arm, 18 (10%) in 32 mg arm, and 8 (5%) in placebo arm. Two
treatment-unrelated deaths were reported in the 32 mg treatment
arm.
“As someone who has spent his career studying everyday
functioning in schizophrenia, I see disability as the most
important treatment target for people with schizophrenia,” stated
Philip Harvey, Ph.D., Leonard M. Miller Professor of
Psychiatry and Director of the Division of Psychology at
the University of Miami Miller School of Medicine. “The substantial
improvements in the PSP scale with the 64 mg dose are tremendously
encouraging. These study results represent a very important outcome
in a study of a potential treatment of negative symptoms, one of
the most important drivers of everyday disability and a critical
unmet medical need for patients with schizophrenia. The consistency
in treatment effects, in terms of overall negative symptoms and of
the most important subtype, reduced emotional experience, between
the previous Phase 2b study and the current one is encouraging. The
increased placebo effect from the first to second study seems to be
the only reason that the study did not meet its primary
endpoint.”
“We are encouraged by the results obtained in this study which
expand upon the outcome of the Phase 2b study that showed
improvements in the primary endpoint and in multiple secondary
endpoints,” said Dr. Remy Luthringer, Executive Chairman and Chief
Executive Officer of Minerva. “Even though this study didn’t
achieve its primary and key secondary endpoints, primarily due to a
larger than expected placebo effect at Week 12, results obtained
with the 64 mg dose including the early onset of effect and
functional improvement as measured by PSP suggest roluperidone
merits continued investigation for the treatment of primary
negative symptoms. We intend to consult with the US FDA about the
next steps in the development of roluperidone for this indication
after we complete the analysis of the study data. I would like to
express our sincere appreciation to all of the patients,
caregivers, the investigators and their staff who participated in
this trial.”
The company will hold a webcast event on Monday, June 1, 2020 at
8:30 a.m. to discuss additional data from this study and to provide
further insight into the roluperidone Phase 3 trial.
About Minerva Neurosciences
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 March 31, 2020,
filed with the Securities and Exchange Commission on May 4,
2020. 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
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