Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, today
announced that data from the Phase 2 ASCEND trial of AXS-05 in
major depressive disorder (MDD) will be presented in oral and
poster sessions at the 2019 Annual Meeting of the American Society
for Clinical Psychopharmacology (ASCP), to be held in Scottsdale,
Arizona, May 28-31. Axsome will also give today a poster
presentation on the clinical development of AXS-05 in
neuropsychiatric disorders at the 2019 American Psychiatric
Association (APA) Annual Meeting in San Francisco, California.
AXS-05 is a novel, oral, investigational NMDA receptor antagonist
with multimodal activity.
Below are the details of the presentations:
American Society for Clinical Psychopharmacology (ASCP)
Annual Meeting:Oral
PresentationTitle: AXS-05, Oral NMDA
Receptor Antagonist with Multimodal Activity, in Major Depressive
Disorder: Results of a Phase 2, Double-Blind, Active-Controlled
TrialDate: Tuesday, May 28,
2019Time: 2:54 PM – 3:05 PM Mountain Time
Poster
PresentationTitle: Efficacy and
Safety of AXS-05, an Oral NMDA Receptor Antagonist with Multimodal
Activity, in Major Depressive Disorder: Results of a Phase 2,
Double-Blind, Active-Controlled TrialPoster
Number: W43 Date: Wednesday, May 29,
2019 Time: 11:15 AM – 1:00 PM Mountain
Time
American Psychiatric Association (APA) Annual
Meeting:
Poster Presentation
Title: AXS-05: A Mechanistically Novel Oral
Therapeutic in Development for Neuropsychiatric Disorders
Poster Number: P7-141 Date:
Tuesday, May 21, 2019 Time: 10:00
AM – 12:00 PM Pacific Time
A copy of the posters will be available shortly after the
meetings on Axsome’s website at www.axsome.com.
About AXS-05
AXS-05 is a novel, oral, 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 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
available therapies for depression. 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
30 issued U.S. and international patents which provide protection
out to 2034. 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), and a Phase 2/3
trial in agitation associated with Alzheimer’s disease (AD). AXS-05
is also being developed for major depressive disorder (MDD) and
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. The Axsome Pain and Primary Care business
unit (Axsome PPC) houses Axsome’s pain and primary care assets,
including AXS-02 and AXS-06, and intellectual property which covers
these and related product candidates and molecules being developed
by Axsome and others. AXS-02 is being developed for osteoporosis,
the pain of knee osteoarthritis, and chronic low back pain. AXS-06
is being developed for osteoarthritis and rheumatoid arthritis.
AXS-02, AXS-05, AXS-06, 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.
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, 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; 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. 200 Broadway, 3rd
Floor New York, NY 10038 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Apr 2023 to Apr 2024