Axsome Therapeutics Presents Data from GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder at the 2020 American Socie...
May 29 2020 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders, today announced that data from the
GEMINI Phase 3 trial of AXS-05 in major depressive disorder (MDD)
will be presented in oral and poster sessions at the 2020 Annual
Meeting of the American Society for Clinical Psychopharmacology
(ASCP), to be held virtually, May 29-30. AXS-05
(dextromethorphan/bupropion modulated delivery tablet) is a novel,
oral, investigational NMDA receptor antagonist with multimodal
activity.
Below are the details of the presentations:
Oral
PresentationTitle: Efficacy and Safety of
AXS-05, an Oral NMDA Receptor Antagonist with Multimodal Activity,
in Major Depressive Disorder: Results from the GEMINI Phase 3,
Double-Blind, Placebo-Controlled TrialDate:
Saturday, May 30, 2020Time: 3:55 PM – 4:05 PM
Eastern Time
Poster
PresentationTitle: Efficacy and
Safety of AXS-05, an Oral NMDA Receptor Antagonist with Multimodal
Activity, in Major Depressive Disorder: Results from the GEMINI
Phase 3, Double-Blind, Placebo-Controlled Trial
Date: Saturday, May 30, 2020
Time: 12:45 PM – 2:15 PM Eastern
Time
A copy of the presentations will be available
shortly after the meeting on Axsome’s website at
www.axsome.com.
About AXS-05
AXS-05 is a novel, oral, patent-protected,
investigational NMDA receptor antagonist with multimodal activity
under development for the treatment of Alzheimer’s disease
agitation, 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, a sigma-1 receptor agonist, an inhibitor of the
serotonin and norepinephrine transporters, a nicotinic
acetylcholine receptor antagonist, and an inhibitor of microglial
activation. 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 42 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, as well
as Fast Track designations for the treatment of Alzheimer’s disease
agitation and treatment resistant depression. AXS-05 is not
approved by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders for which there are limited
treatment options. For the many people facing unsatisfactory
treatments for CNS disorders, Axsome accelerates the invention and
adoption of life-changing medicines. Axsome’s core CNS product
candidate portfolio includes five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being
developed for major depressive disorder (MDD), treatment resistant
depression (TRD), Alzheimer’s disease (AD) agitation, and as
treatment for smoking cessation. AXS-07 is being developed for the
acute treatment of migraine. AXS-12 is being developed for the
treatment of narcolepsy. AXS-14 is being developed for
fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.
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
discontinuation of the bupropion treatment arm of the ADVANCE-1
study in accordance with the independent data monitoring
committee’s recommendations); the potential for the MOMENTUM
clinical trial to provide a basis for approval of AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment; the potential for the
ASCEND clinical trial, combined with the GEMINI clinical trial
results, 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; unforeseen circumstances or other
disruptions to normal business operations arising from or related
to COVID-19; 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. The data
disclosed in this press release are considered topline data and
subject to further statistical review and the final results may
vary.
Axsome Contact: Mark Jacobson
Chief Operating Officer Axsome Therapeutics, Inc. 200 Broadway, 3rd
Floor New York, NY 10038 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
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