Axsome Therapeutics Announces AXS-05 Presentation at the 2018 Alzheimer’s Association International Conference
July 17 2018 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, today
announced a poster presentation on AXS-05 at the 2018 Alzheimer’s
Association International Conference (AAIC) on July 23, 2018 in
Chicago, IL. AXS-05 is a novel, oral, investigational medicine
consisting of dextromethorphan and bupropion, in late-stage
development for the treatment of agitation associated with
Alzheimer’s disease.
The presentation will highlight data correlating
AXS-05 drug levels from Phase 1 trials to neurotransmitter receptor
activation and to improvements in agitation symptoms in patients
with Alzheimer’s disease. The current status of the Company’s
ongoing Phase 2/3 trial of AXS-05 in agitation associated with
Alzheimer’s disease, the ADVANCE-1 trial, will also be
presented.
Below are the details of the presentation, which
will be given by Cedric O’Gorman, MD, Senior Vice President,
Clinical Development and Medical Affairs of Axsome:
Poster
Presentation:Title: AXS-05
(Dextromethorphan/Bupropion): An Innovative Treatment in Clinical
Development for Agitation Associated with Alzheimer’s
DiseasePoster Session: P2-01Poster
Number: P2-033Date: Monday, July 23,
2018Time: 9:30 AM – 4:15 PM Central Time
AXS-05 combines glutamatergic, monoaminergic,
and anti-inflammatory mechanisms of action. The biological pathways
targeted by these pharmacological actions have been implicated in a
wide range of CNS disorders including depression, neuropsychiatric
symptoms of Alzheimer’s disease, and nicotine dependence.
A copy of the poster presentation will be
available shortly after the meeting on Axsome’s website at
www.axsome.com.
About AXS-05
AXS-05 is a novel, oral, investigational
medicine under development for the treatment of central nervous
system (CNS) disorders. AXS-05 consists of bupropion and
dextromethorphan and utilizes Axsome’s metabolic inhibition
technology. Dextromethorphan is an NMDA receptor antagonist,
sigma-1 receptor agonist, nicotinic acetylcholine receptor
antagonist, and inhibitor of the serotonin and norepinephrine
transporters. Bupropion serves to increase the bioavailability of
dextromethorphan, and is a norepinephrine and dopamine reuptake
inhibitor, and a nicotinic acetylcholine receptor antagonist.
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 product candidate
portfolio includes five clinical-stage candidates, AXS-02, AXS-05,
AXS-06, AXS-07, and AXS-09. AXS-05 is currently in a Phase 3 trial
in treatment resistant depression (TRD), a Phase 2/3 trial in
agitation associated with Alzheimer’s disease (AD), a Phase 2 trial
in Major Depressive Disorder (MDD), and a Phase 2 trial in smoking
cessation. AXS-02 is currently in a Phase 3 trial in knee
osteoarthritis (OA) associated with bone marrow lesions (BMLs) with
an additional Phase 3 trial planned in chronic low back pain (CLBP)
associated with Modic changes (MCs). AXS-07 is being developed for
the acute treatment of migraine. AXS-06 is being developed for the
treatment of osteoarthritis and rheumatoid arthritis and for the
reduction of the risk of NSAID-associated gastric ulcers. AXS-02,
AXS-05, AXS-06, AXS-07, and AXS-09 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”. The Company 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 the Company’s ongoing clinical trials
and anticipated clinical trials for its current product candidates,
including statements regarding the timing of initiation, interim
analyses and completion of the trials; the timing of and the
Company’s ability to obtain and maintain U.S. Food and Drug
Administration or other regulatory authority approval of, or other
action with respect to, its product candidates; 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. 25 Broadway, 9th
Floor New York, NY 10004 Tel: 212-332-3243
Email: mjacobson@axsome.comwww.axsome.com
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