Full Press Release Details
Axsome Therapeutics Completes Patient
Randomization in the STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression
NEW YORK, January 22, 2020 (Globe Newswire)
- 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- sberg Depression Rating Scale (MADRS)
after 6 weeks of treatment.
About Treatment Resistant Depression
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.
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
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.
Senior Vice President, Operations
Axsome Therapeutics, Inc.
200 Broadway, 3rd Floor
Email: mjacobson@axsome.com