Axsome Therapeutics Completes Patient Randomization in the STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression...
January 22 2020 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, today
announced the completion of patient randomization in the STRIDE-1
study, a Phase 3, randomized, double-blind, active-controlled trial
of AXS-05 in patients with treatment resistant depression (TRD).
AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a
novel, oral, investigational NMDA receptor antagonist with
multimodal activity. Axsome remains on track to report topline
results from STRIDE-1 in the first quarter of 2020.
About the STRIDE-1 Trial
STRIDE-1 (Symptom Treatment in Resistant
Depression 1) is a Phase 3, randomized, double-blind, active
controlled trial to assess the efficacy and safety of AXS-05 in the
treatment of treatment resistant depression (TRD). Patients with
major depressive disorder (MDD) who have previously failed one or
two antidepressant treatments are treated in an open-label fashion
with bupropion during a 6-week lead-in period. Patients who fail to
respond to bupropion during this lead-in period are randomized in a
1:1 ratio to treatment with bupropion or AXS-05 in a double-blind
fashion for 6 weeks. The primary endpoint is the change in the
Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks of
treatment.
About Treatment Resistant Depression
(TRD)
Patients diagnosed with major depressive
disorder (MDD) are defined as having TRD if they have failed two or
more antidepressant therapies. MDD is a serious condition
characterized by depressed mood or a loss of interest or pleasure
in daily activities consistently for at least a two-week period,
and which impairs social, occupational, educational, or other
important functioning. According to the National Institute of
Health, an estimated 7.1% of U.S. adults experience MDD each year.
Nearly two-thirds of diagnosed and treated patients do not
experience adequate treatment response with first-line therapy, and
the majority of these initial failures also fail second-line
treatment.
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 designation for the
treatment of treatment resistant depression. 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; 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. 200 Broadway, 3rd
Floor New York, NY 10038 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
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