Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced a presentation of data from its ACCORD Phase 3 clinical
trial of AXS-05, a novel, oral NMDA receptor antagonist and sigma-1
receptor agonist, in patients with Alzheimer’s disease agitation
(ADA), at the 16th Clinical Trials on Alzheimer’s Disease (CTAD)
Conference, being held in Boston from Oct. 24-27.
“Agitation associated with Alzheimer's dementia
is a common and impactful behavioral symptom causing significant
distress for patients and their care partners,” said George
Grossberg, MD, study author, Professor and Director of the Division
of Geriatric Psychiatry at the Saint Louis University School of
Medicine. “Agitation is also a significant risk factor for early
admission to long term care facilities. The outcome of the ACCORD
trial with AXS-05 demonstrating positive efficacy results in
agitation associated with Alzheimer's dementia, while being
generally well-tolerated, is welcome news."
Results of the trial demonstrated rapid and
sustained clinical response in patients with ADA during the
open-label AXS-05 treatment phase. During the placebo-controlled
randomized withdrawal phase, AXS-05 statistically significantly
delayed the time to relapse of agitation symptoms as compared to
placebo. AXS-05 was generally well-tolerated in the trial with no
new safety signals identified.
“Agitation, which is seen in up to 70% of people
with Alzheimer’s disease, is among the most complex, challenging
and costly aspects of care and is associated with multiple negative
outcomes such as increased caregiver burden, morbidity, mortality,
earlier nursing home placement, and overall functional impairment,”
said Cecilia Brain, MD, PhD, Vice President of Medical Affairs at
Axsome. “The detailed efficacy and safety results of the ACCORD
trial support the potential of AXS-05 in this area of significant
unmet medical need.”
The poster will be available for viewing in the
Poster Hall from 7:30 a.m. Eastern Time on Wednesday, Oct. 25 to
4:30 p.m. Eastern Time on Friday, Oct. 27. Poster presenters will
be on hand for discussion from 7:30-8:30 a.m. Eastern Time as well
as during the morning and afternoon coffee breaks each day during
the CTAD conference. The poster will also be available through the
CTAD digital platform.
Details for the presentation are as follows:
Title: Efficacy and Safety Of
AXS-05 in Agitation Associated With Alzheimer’s Disease: Results
From ACCORD, a Phase 3, Double-Blind, Placebo-Controlled, Relapse
Prevention Trial Presenting Author: George
Grossberg, MD, professor and director of the division of geriatric
psychiatry at the Saint Louis University School of Medicine
Poster Number: LP093Theme: New
therapies and clinical trials
About the ACCORD Study
ACCORD (Assessing Clinical Outcomes in
Alzheimer’s Disease Agitation) was a Phase 3, randomized,
double-blind, placebo-controlled, multi-center trial to evaluate
efficacy and safety of AXS-05 in patients with Alzheimer’s disease
(AD) agitation. Patients with a diagnosis of probable Alzheimer’s
disease and clinically meaningful agitation associated with their
disease were enrolled into a 9-week, open-label period, during
which they were treated with AXS-05 and monitored for a sustained
clinical response.
Patients who experienced a sustained clinical
response during the open-label treatment period were then
randomized in a 1:1 ratio, to continue treatment with AXS-05 or to
switch to placebo treatment, in a double-blind fashion for up to 26
weeks. Treatment was continued until either a relapse of agitation
symptoms or the end of the 26-week double-blind period, whichever
occurred first.
The primary endpoint in the study was time from
randomization to relapse of Alzheimer’s disease agitation
calculated by the Kaplan-Meier estimates and the hazard ratio. The
key secondary endpoint, to assess relapse prevention, was the
percentage of patients who relapsed. The primary timepoint for
open-label efficacy assessments was Week 5 and the key secondary
timepoint was Week 2.
About Alzheimer’s Disease (AD) Agitation
Alzheimer’s disease (AD) is a progressive
neurodegenerative disorder characterized by cognitive decline, and
behavioral and psychological symptoms including agitation. AD is
the most common form of dementia and afflicts an estimated 6
million individuals in the United States, a number that is
anticipated to increase to approximately 14 million by
2050.1 Agitation is reported in up to 70% of patients with AD
and is characterized by emotional distress, aggressive behaviors,
disruptive irritability, and disinhibition.2 Agitation in
patients with AD has been associated with increased caregiver
burden, decreased functioning, accelerated cognitive decline,
earlier nursing home placement, and increased
mortality.2-4 There are currently no therapies approved by the
FDA for the treatment of agitation in patients with AD.
About AXS-05
AXS-05 (dextromethorphan-bupropion) is a novel,
oral, patent protected, investigational N-methyl-D-aspartate (NMDA)
receptor antagonist with multimodal activity under development for
the treatment of Alzheimer’s disease (AD) agitation and other
central nervous system (CNS) disorders. AXS-05 utilizes a
proprietary formulation and dose of dextromethorphan and bupropion,
and Axsome’s metabolic inhibition technology, to modulate the
delivery of the components. The dextromethorphan component of
AXS-05 is an uncompetitive NMDA receptor antagonist, also known as
a glutamate receptor modulator, and a sigma-1 receptor agonist. The
bupropion component of AXS-05 serves to increase the
bioavailability of dextromethorphan, and is a norepinephrine and
dopamine reuptake inhibitor. AXS-05 is covered by a robust patent
estate extending out at least to 2037-2040. AXS-05 was granted FDA
Breakthrough Therapy designation for the treatment of Alzheimer’s
disease agitation in June 2020. AXS-05 is not approved by the
FDA for the treatment of AD agitation.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for central
nervous system (CNS) conditions that have limited treatment
options. Through development of therapeutic options with novel
mechanisms of action, we are transforming the approach to treating
CNS conditions. At Axsome, we are committed to developing products
that meaningfully improve the lives of patients and provide new
therapeutic options for physicians. 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
continued commercial success of our Sunosi® and Auvelity® products
and the success of our efforts to obtain any additional
indication(s) with respect to solriamfetol and/or AXS-05; 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 (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected revenues or expenses), futility
analyses and receipt of interim results, which are not necessarily
indicative of the final results of our ongoing clinical trials,
and/or data readouts, 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 statements
regarding the timing of any NDA submission; whether issues
identified by FDA in the complete response letter may impact the
potential approvability of the Company’s NDA for AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment for the MOMENTUM
clinical trial; 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 products and product
candidates, if approved; the Company’s anticipated capital
requirements, including the amount of capital required for the
continued commercialization of Sunosi and Auvelity and for the
Company’s commercial launch of its other product candidates, if
approved, and the potential impact on the Company’s anticipated
cash runway; unforeseen circumstances or other disruptions to
normal business operations arising from or related to COVID-19; 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 Contacts:
Investors:Mark JacobsonChief Operating OfficerAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
Media:
Darren OplandDirector, Corporate CommunicationsAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com
References
- Alzheimer’s Association. 2020 Alzheimer’s Disease Facts and
Figures. Alzheimers Dement. 2020;16(3):391+.
- Tractenberg RE, et al. J Neuropsychiatry Clin Neurosci.
2002;14:11-18.
- Porsteinsson AP, et al. Expert Opin Pharmacother.
2017;18:611-620.
- Rabins PV, et al. Alzheimers Dement. 2013;9:204-207.
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