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 it will host a research and development (R&D)
day with key opinion leaders (KOLs) on Thursday, October 18, 2018
in New York City. The event will highlight AXS-05, the company’s
most advanced CNS product candidate, and unmet needs in agitation
associated with Alzheimer’s disease (AD). AXS-05 is in a Phase 2/3
randomized, double-blind, controlled trial (the ADVANCE-1 study) in
patients with agitation associated with AD. An interim analysis for
futility of the ADVANCE-1 study is anticipated in the fourth
quarter of 2018.
The event will feature presentations from
Jeffrey Cummings, MD, ScD (Cleveland Clinic) who will discuss the
prevalence and outcomes of neuropsychiatric symptoms of AD, and
Clive Ballard, MD, MSc (University of Exeter) who will discuss the
challenges in the current management of agitation associated with
AD and possible future pharmacotherapeutic directions, including
the potentially relevant pharmacology of AXS-05 for this
indication. The presenters will be available to answer questions
following their presentations.
The Axsome executive management team will also
provide an update on the ongoing clinical development of AXS-05 as
well as on the rest of the Company’s CNS pipeline.
KOL Presenters:
- Jeffrey Cummings, MD, ScD. Director of the
Center for Neurodegeneration and Translational Neuroscience;
Director Emeritus, Cleveland Clinic Lou Ruvo Center for Brain
Health; and Professor of Neurology, at the Cleveland Clinic
Lerner College of Medicine
- Clive Ballard, MD, MRCPsych, MSc. Pro-Vice
Chancellor and Executive Dean of Medicine, University of
Exeter
AXS-05 is a novel, oral, investigational
medicine consisting of dextromethorphan (an NMDA receptor
antagonist, sigma-1 receptor agonist, and serotonin and
norepinephrine reuptake inhibitor) and bupropion (a norepinephrine
and dopamine reuptake inhibitor, which also increases the
bioavailability of dextromethorphan), under development for the
treatment of CNS disorders. In addition to the Phase 2/3 trial in
agitation associated with AD, AXS-05 is also being evaluated in a
Phase 3 trial in treatment resistant depression (TRD), a Phase 2
trial in major depressive disorder, and a Phase 2 trial in smoking
cessation. AXS-05 has been granted U.S. Food and Drug
Administration Fast Track designations for TRD and for agitation
associated with AD.
This event is intended for institutional
investors, sell-side analysts, and business development
professionals only. Please RSVP in advance if you plan to attend,
as space is limited. To reserve a seat email Kimberly Kenney at
kkenney@axsome.com.
A live and archived webcast of the event, with
slides, can be accessed on the investor page of Axsome’s website at
www.axsome.com.
KOL Credentials
- Jeffrey Cummings, MD, ScDDr. Jeffrey Cummings
is the Director of the Center for Neurodegeneration and
Translational Neuroscience and Director Emeritus of the Lou Ruvo
Center for Brain Health at the Cleveland Clinic Neurological
Institute. He holds a faculty position as Professor of Medicine at
the Cleveland Clinic Lerner College of Medicine of Case Western
Reserve University. He has previously held numerous faculty and
directorship positions at the UCLA school of Medicine, Boston
University School of Medicine, University of Nevada College of
Liberal Arts, University of Nevada Las Vegas School of Medicine,
and the Department of Veterans Affairs. He is past President of the
Behavioral Neurology Society and of the American Neuropsychiatric
Association.Dr. Cummings originated the Neuropsychiatric Inventory
(NPI), and he has published over 700 articles and over 40 books. He
is the recipient of numerous awards including the Bengt Winblad
Lifetime Achievement Award in Alzheimer’s Research and the Ronald
and Nancy Reagan Research Award from the national Alzheimer’s
Association.
- Clive Ballard, MD, MScProfessor Ballard has
held faculty positions at King’s College’s Institute of Psychiatry
as Professor of Age-Related Diseases, Co-Director of the Biomedical
Research Unit for Dementia, and Co-Director of the Wolfson Center
for Age-Related Disease; University of Newcastle as Professor of
Old Age Psychiatry; University of Birmingham as a Lecturer in
Psychiatry; and, currently, as Pro-Vice Chancellor and Executive
Dean of Medicine at the University of Exeter. He has also served as
Director of Research for the Alzheimer’s Society.Author of over 500
articles and investigator on more than 25 clinical trials, Prof.
Ballard is an internationally recognized researcher, lecturer, and
teacher in psychiatry with subspecialty expertise in geriatric
populations and dementia.
About the ADVANCE-1 Study
ADVANCE-1 (Addressing Dementia Via
Agitation-Centered Evaluation 1) is a Phase 2/3 multicenter,
randomized, double-blind, controlled trial to evaluate the efficacy
and safety of AXS-05 in patients with agitation associated with
Alzheimer’s disease. Approximately 435 patients will be randomized
in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 5
weeks. The primary efficacy measure is the Cohen-Mansfield
Agitation Inventory (CMAI). The trial incorporates two interim
analyses to be performed by an independent data monitoring
committee. The first interim analysis will be performed on the
first approximately 30% of the target number of subjects to assess
futility. The second interim analysis will be performed on the
first approximately 60% of the target number of subjects to assess
efficacy.
About Alzheimer’s Disease (AD)
Agitation
Alzheimer’s disease (AD) is a progressive
neurodegenerative disorder that manifests initially as
forgetfulness advancing to severe cognitive impairment and memory
loss. It afflicts an estimated 5 million individuals in the United
States, a number that is anticipated to increase to approximately
14 million by 2050. In addition to cognitive decline, individuals
diagnosed with AD frequently experience behavioral and
psychological symptoms including agitation which is reported in
approximately 45% of patients. Agitation is characterized by
emotional distress, aggressive behaviors, disruptive irritability,
and disinhibition. Agitation in patients with AD has been
associated with increased caregiver burden, decreased functioning,
earlier nursing home placement, and increased mortality. There are
currently no therapies approved by the FDA for the treatment of
agitation in patients with AD.
About AXS-05
AXS-05 is a novel, oral, investigational drug
product 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 an investigational drug product 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) and 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 website at www.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
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