Multi-center trial to enroll approximately 324 patients at
approximately 40 clinical sites in U.S. and Europe
WALTHAM, Mass., April 09, 2018 (GLOBE NEWSWIRE) --
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
the screening of the first patient in a Phase 2b trial of MIN-117
(Study MIN-117C03) to reduce the symptoms of patients diagnosed
with major depressive disorder (MDD).
The primary objective of the trial is to evaluate
the efficacy of two fixed doses of MIN-117, 5.0 milligrams (mg) and
2.5 mg, compared with placebo in reducing the symptoms of major
depression as measured by the change in the Montgomery-Asberg
Depression Rating Scale (MADRS) total score over six weeks of
treatment. Secondary objectives include: (1) assessment of
the change from baseline in symptoms of anxiety using the Hamilton
Anxiety Scale (HAM-A); (2) the change in severity of illness using
the Clinical Global Impression of Severity Scale (CGI-S) and
Clinical Global Impression of Improvement Scale (CGI-I); and (3)
safety over six weeks of treatment.
"While existing therapies for MDD are available,
their effectiveness is limited due to unacceptable side effects,
particularly cognitive impairment and sexual dysfunction," said Dr.
Remy Luthringer, Chief Executive Officer of Minerva. "These
shortcomings warrant the exploration of new treatment strategies
with molecules such as MIN-117 that possess an innovative and rich
pharmacological profile. In addition to the primary endpoint of
reducing the symptoms of major depression, we plan to assess
anxiety, cognition, sexual function, sleep, validated depression
biomarkers and onset of action to further define the product
profile of MIN-117 as an agent that can potentially address these
shortcomings."
The study population will consist of adults with a
diagnosis of moderate or severe MDD with anxious distress and
without psychotic features. Based upon previous clinical
observations, the Company believes that patients with MDD who also
have symptoms of anxiety may benefit from treatment with
MIN-117.
Approximately 324 patients are expected to be
enrolled at approximately 40 sites in the U.S. and Europe.
Patients will be randomized to one of three arms, including placebo
and the two dosage arms, in a 2:1:1 ratio, resulting in
approximately 162 patients in the placebo group and 81 patients in
each of the two MIN-117 treatment groups. The study design
includes a screening phase of up to three weeks, a six-week
double-blind treatment phase and a two-week post-study follow-up
period. Top line results of the trial are expected in the
first half of 2019.
About MIN-117
The pharmacological effects of MIN-117 are related
to serotonin and dopamine, two neurotransmitters in the brain.
MIN-117 is meant to block a specific subtype of serotonin receptor
called 5-HT1A. When 5-HT1A is blocked, anxiety and mood can be
regulated. In addition, MIN-117 is meant to prevent the reuptake of
serotonin and dopamine, which increases the amount of serotonin and
dopamine in the brain, which is tied to an improvement in mood in
individuals suffering from MDD. MIN-117 is also meant to modulate
the levels of Alpha-1a and 1b, which further modulates serotonin
and dopamine.
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 Phase 3 clinical development for
schizophrenia; seltorexant (MIN-202 or JNJ-42847922) in Phase 2b
clinical development for insomnia and 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 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 MIN-117; the timing and
scope of future clinical trials and results of clinical trials with
this compound; 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 MIN-117 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 MIN-117 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 Annual Report on Form 10-K for the year
ended December 31, 2017, filed with the Securities and
Exchange Commission on March 12, 2018. 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. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376