Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, today
announced the completion of patient enrollment in the GEMINI study,
a Phase 3, randomized, double-blind, placebo-controlled trial of
AXS-05 in patients with major depressive disorder (MDD). AXS-05
(dextromethorphan/bupropion modulated delivery tablet) is a novel,
oral, investigational NMDA receptor antagonist with multimodal
activity. Axsome remains on track to report topline results from
GEMINI in the fourth quarter of 2019.
About the GEMINI Trial
GEMINI (Glutamatergic and Monoaminergic
Modulation in Depression) is a Phase 3, randomized, double-blind,
multicenter, placebo-controlled trial of AXS-05 in patients with
major depressive disorder (MDD). Approximately 300 patients with a
confirmed diagnosis of moderate to severe MDD will be randomized in
a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.
Assessments including the Montgomery-Åsberg Depression Rating Scale
(MADRS), safety parameters, clinician-rated scales, as well as
patient-reported outcome measures will be conducted throughout the
study.
About Major Depressive Disorder
(MDD)
Major depressive disorder (MDD) is a
debilitating, chronic, biologically-based disorder characterized by
low mood, inability to feel pleasure, feelings of guilt and
worthlessness, low energy, and other emotional and physical
symptoms, and which impairs social, occupational, educational, or
other important functioning. In severe cases, MDD can result in
suicide. According to the National Institutes of Health, an
estimated 7.1% of U.S. adults, or approximately 17.3 million,
experience MDD each year1. According to the World Health
Organization (WHO), depression is the leading cause of disability
worldwide, and is a major contributor to the overall global burden
of disease2. Nearly two-thirds of diagnosed and treated patients do
not experience adequate treatment response with currently available
first-line therapy3, highlighting the need for additional therapies
with new mechanisms of action. The majority of patients who
initially fail also fail second-line treatment. Patients diagnosed
with MDD are defined as having treatment resistant depression (TRD)
if they have failed to respond to two or more antidepressant
therapies.
About AXS-05
AXS-05 is a novel, oral, patent-protected,
investigational NMDA receptor antagonist with multimodal activity
under development for the treatment of major depressive disorder
and other central nervous system (CNS) disorders. AXS-05 consists
of a proprietary formulation and dose of dextromethorphan and
bupropion and utilizes Axsome’s metabolic inhibition technology.
The dextromethorphan component of AXS-05 is a non-competitive
N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a
glutamate receptor modulator, which is a novel mechanism of action,
meaning it works differently than currently approved therapies for
major depressive disorder. The dextromethorphan component of AXS-05
is also a sigma-1 receptor agonist, nicotinic acetylcholine
receptor antagonist, and inhibitor of the serotonin and
norepinephrine transporters. The bupropion component of AXS-05
serves to increase the bioavailability of dextromethorphan, and is
a norepinephrine and dopamine reuptake inhibitor, and a nicotinic
acetylcholine receptor antagonist. AXS-05 is covered by more than
37 issued U.S. and international patents which provide protection
out to 2034. AXS-05 has been granted U.S. Food and Drug
Administration (FDA) Breakthrough Therapy designation for the
treatment of MDD. AXS-05 is not approved by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders for which
there are limited treatment options. Axsome’s core CNS product
candidate portfolio includes four clinical-stage candidates,
AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase
3 trial in treatment resistant depression (TRD), a Phase 3 trial in
major depressive disorder (MDD), and a Phase 2/3 trial in agitation
associated with Alzheimer’s disease (AD). AXS-05 is also being
developed for smoking cessation treatment. AXS-07 is currently in a
Phase 3 trial for the acute treatment of migraine. AXS-12 is
currently in a Phase 2 trial in narcolepsy. AXS-05, AXS-07, AXS-09,
and AXS-12 are investigational drug products not approved by the
FDA. For more information, please visit the Company’s website at
axsome.com. The Company may occasionally disseminate material,
nonpublic information on the company website.
References
1. National Institute of Mental Health. (2017). Major
Depression. Retrieved from
https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
2. World Health Organization. Fact Sheets: Depression.
3. Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917
(STAR*D Study).
Forward Looking Statements
Certain matters discussed in this press release
are “forward-looking statements”. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company’s statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
success, timing and cost of our ongoing clinical trials and
anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation, pace of
enrollment and completion of the trials (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected expenses), futility analyses and
receipt of interim results, which are not necessarily indicative of
the final results of our ongoing clinical trials, and the number or
type of studies or nature of results necessary to support the
filing of a new drug application (“NDA”) for any of our current
product candidates; our ability to fund additional clinical trials
to continue the advancement of our product candidates; the timing
of and our ability to obtain and maintain U.S. Food and Drug
Administration (“FDA”) or other regulatory authority approval of,
or other action with respect to, our product candidates (including,
but not limited to, FDA’s agreement with the Company’s plan to
discontinue the bupropion treatment arm of the ADVANCE-1 study in
accordance with the independent data monitoring committee’s
recommendations); the potential for the ASCEND clinical trial to
provide a basis for approval of AXS-05 for the treatment of major
depressive disorder and accelerate its development timeline and
commercial path to patients; the Company’s ability to successfully
defend its intellectual property or obtain the necessary licenses
at a cost acceptable to the Company, if at all; the successful
implementation of the Company’s research and development programs
and collaborations; the success of the Company’s license
agreements; the acceptance by the market of the Company’s product
candidates, if approved; the Company’s anticipated capital
requirements, including the Company’s anticipated cash runway and
the Company’s current expectations regarding its plans for future
equity financings prior to the readout from its Phase 3 trials; and
other factors, including general economic conditions and regulatory
developments, not within the Company’s control. The factors
discussed herein could cause actual results and developments to be
materially different from those expressed in or implied by such
statements. The forward-looking statements are made only as of the
date of this press release and the Company undertakes no obligation
to publicly update such forward-looking statements to reflect
subsequent events or circumstance.
Axsome Contact: Mark Jacobson Senior Vice
President, Operations Axsome Therapeutics, Inc. 25 Broadway, 9th
Floor New York, NY 10004 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
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