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 its GEMINI (Glutamatergic and Monoaminergic
Modulation in Depression) study, a Phase 3, randomized,
double-blind, placebo-controlled trial of AXS-05 in the treatment
of major depressive disorder (MDD). AXS-05 is a novel, oral,
investigational NMDA receptor antagonist with multimodal activity.
Topline results from the GEMINI trial are anticipated in the second
half of 2019.
“Initiation of the placebo-controlled GEMINI
Phase 3 trial continues the expedited clinical development of
AXS-05 in depression. If successfully developed, AXS-05 has the
potential to be the first orally administered NMDA receptor
antagonist approved for the treatment of this debilitating
condition,” said Herriot Tabuteau, MD, Chief Executive Officer of
Axsome. “Based on the results of our recent FDA Breakthrough
Therapy meeting for AXS-05, we believe that either the GEMINI study
in MDD or the ongoing STRIDE-1 trial in treatment resistant
depression, if positive, would, in conjunction with our previously
completed ASCEND trial in MDD, be sufficient to support the filing
of an NDA for AXS-05 for the treatment of MDD. We continue to
anticipate topline results from both the STRIDE-1 and GEMINI trials
in the second half of 2019.”
In March 2019, Axsome received Breakthrough
Therapy Designation from the U.S. Food and Drug Administration
(FDA) for AXS-05 for the treatment of MDD. A Breakthrough Therapy
designation is granted to potentially expedite development and
review timelines for a promising investigational medicine when
preliminary clinical evidence indicates it may demonstrate
substantial improvement on one or more clinically significant
endpoints over available therapies for a serious or
life-threatening condition. AXS-05 has also been granted FDA Fast
Track designations for the treatment of TRD and for the treatment
of agitation associated with Alzheimer’s disease.
About the GEMINI TrialGEMINI
(Glutamatergic and Monoaminergic Modulation in Depression) is a
Phase 3, randomized, double-blind, multicenter, placebo-controlled
trial of AXS-05 in patients with major depressive disorder (MDD).
Approximately 300 patients with a confirmed diagnosis of moderate
to severe MDD will be randomized in a 1:1 ratio to treatment with
AXS-05 or placebo for 6 weeks. Assessments including the
Montgomery-Åsberg Depression Rating Scale (MADRS), safety
parameters, clinician-rated scales, as well as patient-reported
outcome measures will be conducted throughout the study.
About Major Depressive Disorder
(MDD)Major depressive disorder (MDD) is a debilitating,
chronic, biologically-based disorder characterized by low mood,
inability to feel pleasure, feelings of guilt and worthlessness,
low energy, and other emotional and physical symptoms, and which
impairs social, occupational, educational, or other important
functioning. In severe cases, MDD can result in suicide. According
to the National Institutes of Health, an estimated 7.1% of U.S.
adults, or approximately 17.3 million, experience MDD each year1.
According to the World Health Organization (WHO), depression is the
leading cause of disability worldwide, and is a major contributor
to the overall global burden of disease2. Nearly two-thirds of
diagnosed and treated patients do not experience adequate treatment
response with currently available first-line therapy3, highlighting
the need for additional therapies with new mechanisms of action.
The majority of patients who initially fail also fail second-line
treatment. Patients diagnosed with MDD are defined as having
treatment resistant depression (TRD) if they have failed to respond
to two or more antidepressant therapies.
About AXS-05AXS-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 36 issued U.S. and international
patents which provide protection out to 2034. 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 four clinical-stage candidates,
AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase
3 trial in treatment resistant depression (TRD), a Phase 3 trial in
major depressive disorder (MDD), and a Phase 2/3 trial in agitation
associated with Alzheimer’s disease (AD). 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
currently in a Phase 2 trial in narcolepsy. The Axsome Pain and
Primary Care business unit (Axsome PPC) houses Axsome’s pain and
primary care assets, including AXS-02 and AXS-06, and intellectual
property which covers these and related product candidates and
molecules being developed by Axsome and others. AXS-02 is being
developed for osteoporosis, the pain of knee osteoarthritis, and
chronic low back pain. AXS-06 is being developed for osteoarthritis
and rheumatoid arthritis. AXS-02, AXS-05, AXS-06, AXS-07, AXS-09,
and AXS-12 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.
References
1. National Institute of Mental Health. (2017). Major
Depression. Retrieved from
https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
2. World Health Organization. Fact Sheets: Depression.
3. Rush AJ, et al. (2007) Am J. Psychiatry
163:11, pp. 1905-1917 (STAR*D Study).
Forward Looking
StatementsCertain 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, 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 ASCEND clinical trial 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; 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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