Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, announces
continued progress toward NDA filing of AXS-05 in the treatment of
major depressive disorder (MDD), and the generation of new clinical
data to further characterize the antidepressant profile of AXS-05
across a broad spectrum of patients with MDD.
Enrollment has been completed in the COMET
(Clinical Outcomes with NMDA-based Depression Treatment) Phase
3 open-label, long-term safety trial to support the planned
NDA filing of AXS-05 in MDD. In addition, the required number of
patients treated for 6 months has been reached. Filing of the NDA
remains on track for the fourth quarter of 2020.
Axsome is also conducting three Phase 2
open-label efficacy sub-studies of the COMET trial which will
evaluate the efficacy and safety of AXS-05 in three clinically
pertinent MDD patient populations: the COMET-TRD trial in treatment
resistant MDD (TRD), the COMET-AU trial in antidepressant
unresponsive MDD, and the COMET-SI trial in MDD with suicidal
ideation. Efficacy results from these studies are expected in the
fourth quarter of 2020.
Further, Axsome has initiated the MERIT
(Mechanistic Evaluation of Response in TRD) trial, a Phase 2,
double-blind, placebo-controlled, randomized withdrawal study in
patients with TRD. Results from the MERIT trial, which are expected
in the first half of 2021, along with results from the COMET-TRD
trial, which are expected in the fourth quarter of 2020, will
provide clinically useful information with AXS-05 in this treatment
resistant MDD population.
Depression Clinical Program
Update
Major Depressive Disorder (MDD) NDA
- Enrollment has been completed in
the COMET Phase 3, open-label, long-term safety trial of AXS-05 to
support the New Drug Application (NDA) filing in MDD. Nearly 900
patients have been enrolled, of whom more than 500 have been
treated for at least 6 months to date. At least 300 patients
treated for 6 months and 100 patients treated for one year are
required for the NDA filing. Axsome remains on track to achieve the
required number of patients treated for one year in the fourth
quarter.
- Axsome previously announced that it
had completed a pre-NDA meeting for AXS-05 in MDD with the U.S.
Food and Drug Administration (FDA) to reach agreement on the
proposed content and format of the Company’s planned NDA
submission, including the clinical and nonclinical requirements.
Based on the feedback from the FDA, the Company believes its
regulatory data package will be sufficient to support an NDA for
AXS-05 in MDD, and Axsome remains on track to submit the planned
NDA in the fourth quarter of 2020.
Treatment Resistant MDD (TRD)
- COMET-TRD Trial – Axsome is
conducting the COMET-TRD trial, a Phase 2 open-label sub-study
evaluating the efficacy and safety of AXS-05 in TRD patients. The
trial will include approximately 70 patients who have had ongoing
symptoms of depression despite receiving treatment with two or more
prior antidepressants during the current major depressive episode.
The trial endpoints will include the change from baseline in the
Montgomery-Åsberg Depression Rating Scale (MADRS) total score,
clinical response, and remission. Topline results from the
COMET-TRD trial are expected in the fourth quarter of 2020.
- MERIT Trial – Axsome is conducting
the MERIT trial, a Phase 2, double-blind, placebo-controlled,
randomized withdrawal study of AXS-05 in patients with TRD. The
trial will include approximately 50 patients who have had ongoing
symptoms of depression despite receiving treatment with two or more
prior antidepressants during the current major depressive episode.
In this trial, patients who experience a sustained remission of
depressive symptoms after treatment with open-label AXS-05 will be
randomized to continued treatment with AXS-05 or to placebo in a
double-blind fashion. The primary endpoint of the trial is the time
to relapse of depressive symptoms. Topline results from the MERIT
trial are expected in the first half of 2021.
- The MERIT and COMET-TRD trials are
being conducted in lieu of the previously planned Phase 3 trial in
TRD. This approach will more quickly generate clinically useful
information with AXS-05 in this treatment resistant MDD population,
starting as early as the fourth quarter of 2020.
Antidepressant Unresponsive MDD
- COMET-AU Trial – Axsome is
conducting the COMET-AU trial, a Phase 2 open-label sub-study
evaluating the efficacy and safety of AXS-05 in patients with
antidepressant unresponsive (AU) MDD. The trial will include
approximately 150 patients with ongoing symptoms of depression
despite receiving one standard antidepressant pharmacotherapy. The
trial endpoints will include the change from baseline in the MADRS
total score, clinical response, and remission. Topline results from
the COMET-AU trial are expected in the fourth quarter of 2020.
MDD with Suicidal Ideation
- COMET-SI Trial – Axsome is
conducting the COMET-SI trial, a Phase 2 open-label sub-study
evaluating the efficacy and safety of AXS-05 in MDD patients with
suicidal ideation (SI). The trial will include approximately 30
patients. The trial endpoints will include the resolution of
suicidal ideation. Topline results from the COMET-SI trial are
expected in the fourth quarter of 2020.
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 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 initial failures
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-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,
Alzheimer’s disease agitation, 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, a sigma-1
receptor agonist, an inhibitor of the serotonin and norepinephrine
transporters, a nicotinic acetylcholine receptor antagonist, and an
inhibitor of microglial activation. 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 42 issued U.S. and international patents which provide
protection out to 2034. AXS-05 has been granted U.S. Food and Drug
Administration Breakthrough Therapy designation for major
depressive disorder, Fast Track designation for treatment resistant
depression, and Breakthrough Therapy and Fast Track designations
for Alzheimer’s disease agitation. AXS-05 is not approved by the
FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders for which there are limited
treatment options. For the many people facing unsatisfactory
treatments for CNS disorders, Axsome accelerates the invention and
adoption of life-changing medicines. 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 being
developed for major depressive disorder (MDD), treatment resistant
depression (TRD), Alzheimer’s disease (AD) agitation, and as
treatment for smoking cessation. AXS-07 is being developed for the
acute treatment of migraine. AXS-12 is being developed for the
treatment of narcolepsy. AXS-14 is being developed for
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.
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, accessed October 9, 2018,
http://www.who.int/en/news-room/fact-sheets/detail/depression.
3. Rush AJ, et al. (2007) Am J. Psychiatry
163:11, pp. 1905-1917 (STAR*D Study).
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
discontinuation of 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 JacobsonChief Operating
OfficerAxsome Therapeutics, Inc.22 Cortlandt Street, 16th Floor New
York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com
www.axsome.com
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Apr 2023 to Apr 2024