NEW YORK, July 17, 2018 (GLOBE NEWSWIRE) -- 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 Disease
Poster Session: P2-01
Poster Number: P2-033
Date: Monday, July 23, 2018
Time: 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.com
www.axsome.com
