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 is accelerating the completion of the ADVANCE-1
Phase 2/3 trial of AXS-05 in patients with Alzheimer’s disease (AD)
agitation to ensure the safety of this vulnerable patient
population during the COVID-19 pandemic, while maintaining the
integrity of the clinical trial. AXS-05 (dextromethorphan/bupropion
modulated delivery tablet) is a novel, oral, investigational NMDA
receptor antagonist with multimodal activity. Randomizations into
the study have concluded and patient participation is concluding.
With the acceleration of trial completion, topline results from
ADVANCE-1 are now expected in early second quarter of 2020, versus
previous guidance of the third quarter of 2020.
The decision to accelerate the completion of
this trial was made in light of the newly issued U.S. Food and Drug
Administration (FDA) Guidance on Conduct of Clinical Trials of
Medical Products during COVID-19 Pandemic, which discusses the
potential impact of the pandemic on the conduct of clinical trials
and on the resulting need to ensure the safety of trial
participants. The ADVANCE-1 trial is enrolling only patients 65
years of age or older, the demographic at highest risk for COVID-19
related fatalities. The conclusion of patient randomization and
participation in the ADVANCE-1 trial enables patient compliance
with recent and evolving COVID-19 related national, state and local
government directives and executive orders that persons 65 years
and older isolate at home.
In the original design of the trial,
approximately 435 patients were to be randomized in a 1:1:1 ratio
to receive AXS-05, bupropion, or placebo for 5 weeks (approximately
145 patients per treatment arm). The AXS-05 and placebo arms are
fully enrolled and more than 90% of patients in these arms are
estimated to have completed the study. In December 2018, an
independent data monitoring committee (IDMC) performed an
unblinded, pre-specified interim analysis for futility on the first
approximately 30% of the targeted number of patients. The IDMC
recommended continuation of the AXS-05 and placebo treatment arms
and no further randomization of patients to the bupropion treatment
arm. Subsequently, patients were randomized in a 1:1 ratio to
receive AXS-05 or placebo.
About the ADVANCE-1 Trial
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. The primary efficacy measure is the
Cohen-Mansfield Agitation Inventory (CMAI).
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, patent-protected,
investigational NMDA receptor antagonist with multimodal activity
under development for the treatment of major depressive disorder
and other central nervous system (CNS) disorders. AXS-05 consists
of a proprietary formulation and dose of dextromethorphan and
bupropion and utilizes Axsome’s metabolic inhibition technology.
The dextromethorphan component of AXS-05 is a non-competitive
N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a
glutamate receptor modulator, which is a novel mechanism of action,
meaning it works differently than currently approved therapies for
major depressive disorder. The dextromethorphan component of AXS-05
is also a sigma-1 receptor agonist, nicotinic acetylcholine
receptor antagonist, and inhibitor of the serotonin and
norepinephrine transporters. The bupropion component of AXS-05
serves to increase the bioavailability of dextromethorphan, and is
a norepinephrine and dopamine reuptake inhibitor, and a nicotinic
acetylcholine receptor antagonist. AXS-05 is covered by more than
40 issued U.S. and international patents which provide protection
out to 2034. AXS-05 has been granted U.S. Food and Drug
Administration (FDA) Breakthrough Therapy designation for the
treatment of MDD as well as Fast Track designations for the
treatment of treatment resistant depression and for the treatment
of Alzheimer’s disease agitation. 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 core CNS product
candidate portfolio includes five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. 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),
and is being developed for major depressive disorder (MDD). AXS-05
is also being developed for smoking cessation treatment. AXS-07 is
currently in a Phase 3 trial for the acute treatment of migraine.
AXS-12 is being developed for the treatment of narcolepsy. AXS-14
is being developed for the treatment of fibromyalgia. AXS-05,
AXS-07, AXS-09, AXS-12, and AXS-14 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”. 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, 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 expenses), futility analyses and
receipt of interim results, which are not necessarily indicative of
the final results of our ongoing clinical trials, 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,
but not limited to, FDA’s agreement with the Company’s plan to
discontinue the bupropion treatment arm of the ADVANCE-1 study in
accordance with the independent data monitoring committee’s
recommendations); the potential for the MOMENTUM clinical trial to
provide a basis for approval of AXS-07 for the acute treatment of
migraine in adults with or without aura, pursuant to our special
protocol assessment; the potential for the ASCEND clinical trial,
combined with the GEMINI clinical trial results, to provide a basis
for approval of AXS-05 for the treatment of major depressive
disorder and accelerate its development timeline and commercial
path to patients; 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; the Company’s anticipated capital requirements,
including 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 Contact: Mark Jacobson
Chief Operating Officer Axsome Therapeutics, Inc. 200 Broadway, 3rd
Floor New York, NY 10038 Tel: 212-332-3243 Email:
mjacobson@axsome.comwww.axsome.com
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