Minerva Neurosciences Screens First Patient in Phase 2b Trial of MIN-117 to Treat Major Depressive Disorder
April 09 2018 - 8:30AM
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
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. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
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