First patient enrolled in the ADVANCE-1 study
Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, enrolled the
first patient in the ADVANCE-1 (Addressing Dementia Via
Agitation-Centered Evaluation 1) study, a Phase 2/3 trial
evaluating the efficacy and safety of AXS-05 for the treatment of
Alzheimer’s disease (AD) agitation. AXS-05 is a combination 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).
“Agitation is one of the most distressing and
difficult-to-treat behavioral symptoms in patients with Alzheimer’s
disease,” said Jeffrey Cummings, M.D., Sc.D., Professor of
Neurology, and Director of the Center for Neurodegeneration and
Translational Neuroscience, at the Cleveland Clinic Lerner College
of Medicine. “It is common, being reported in about half of
patients, is one of the primary reasons for early nursing home
placement, and is associated with increased mortality. NMDA
receptor antagonism, sigma-1 receptor agonism, and serotonin and
norepinephrine reuptake inhibition may be relevant mechanisms in
this condition. New treatments are needed for agitation and
progress in this area is a welcome advance.”
“Agitation places a heavy burden on patients
with Alzheimer’s disease and their caregivers,” said Marc Agronin,
M.D., Vice President of Behavioral Health and Clinical Research at
Miami Jewish Health, and Affiliate Associate Professor of
Psychiatry and Neurology at University of Miami Miller School of
Medicine. “Unfortunately there is currently no FDA-approved
medication for this condition. The mechanisms of action of AXS-05
may hold promise in treating Alzheimer’s agitation. We look forward
to learning more about AXS-05 and its potential to relieve the
symptoms of agitation through the ADVANCE-1 trial.”
“The initiation of the ADVANCE-1 trial reflects
Axsome’s continued commitment to developing treatments for serious
CNS disorders for which there are limited treatment options,” said
Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “The
unique pharmacology of AXS-05 lends itself to the potential
treatment of a variety of CNS disorders. With the STRIDE-1 trial in
treatment resistant depression also underway, AXS-05 is now being
evaluated in late-stage clinical trials in two separate CNS
indications.”
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). This trial incorporates
a planned interim analysis by an independent data monitoring
committee to assess the assumptions used to determine the sample
size of the trial.
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 typically 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 utilizes Axsome’s technology of
combining bupropion and dextromethorphan. Dextromethorphan is an
NMDA receptor antagonist, sigma-1 receptor agonist, 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 two late-stage candidates, AXS-05 and AXS-02.
AXS-05 is currently in a Phase 3 trial in treatment resistant
depression (TRD) and a Phase 2/3 trial in agitation in patients
with Alzheimer’s disease (AD). AXS-02 is currently in Phase 3
trials in complex regional pain syndrome (CRPS) and 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-05 and AXS-02 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”. 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, interim
analyses and completion of the trials; the timing of and our
ability to obtain and maintain U.S. Food and Drug Administration or
other regulatory authority approval of, or other action with
respect to, our 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
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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