First patient enrolled in the ASCEND study
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 the ASCEND (Assessing Clinical Episodes in
Depression) study, a Phase 2 randomized, controlled trial of AXS-05
in major depressive disorder (MDD). AXS-05 is a novel, oral,
glutamatergic and monoaminergic investigational medicine consisting
of dextromethorphan and bupropion. Topline results from the ASCEND
trial are expected in the second half of 2018.
AXS-05 is now being evaluated in two mood
disorder clinical programs—MDD with the ASCEND Phase 2 trial, and
treatment resistant depression (TRD) with the ongoing STRIDE-1
Phase 3 trial. MDD is characterized by consistently depressed mood
that impairs functioning. Patients diagnosed with MDD are defined
as having TRD if they have failed to respond to two or more
antidepressant therapies.
“Axsome is committed to addressing the urgent
need for new treatment options for the millions of patients living
with depression,” said Herriot Tabuteau, MD, Chief Executive
Officer of Axsome. “AXS-05 features multiple novel mechanisms of
action which, along with the recent positive interim futility
analysis of the Phase 3 trial in TRD, support its evaluation in the
broader MDD population. AXS-05 is now being studied in four
clinical trials across four indications. We look forward to a busy
second half of 2018 for AXS-05, with anticipated topline results
from the Phase 2 ASCEND trial in MDD, the first interim analysis of
the Phase 2/3 ADVANCE-1 trial in Alzheimer’s disease agitation, and
the next and final interim analysis for efficacy of the Phase 3
STRIDE-1 trial in TRD.”
About the ASCEND Study
ASCEND (Assessing Clinical Episodes in
Depression) is a Phase 2, double-blind, randomized,
active-controlled, multicenter trial of AXS-05 in patients with
MDD. Approximately 74 patients will be randomized in a 1:1 ratio to
receive AXS-05 or bupropion for 6 weeks. Assessments that will be
conducted throughout the study include safety parameters, the
Montgomery-Åsberg Depression Rating Scale (MADRS), other
clinician-rated scales, as well as patient-reported outcome
measures.
About Major Depressive Disorder
(MDD)
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 6.7% of U.S. adults, or approximately 16 million,
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. 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, investigational drug
product under development for the treatment of central nervous
system (CNS) disorders. AXS-05 consists of bupropion and
dextromethorphan and utilizes Axsome’s metabolic inhibition
technology. Dextromethorphan is an NMDA receptor antagonist,
sigma-1 receptor agonist, nicotinic acetylcholine receptor
antagonist, and inhibitor of the serotonin and norepinephrine
transporters. Bupropion serves to increase the bioavailability of
dextromethorphan, and is a norepinephrine and dopamine reuptake
inhibitor, and a nicotinic acetylcholine receptor antagonist.
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 product candidate
portfolio includes five clinical-stage candidates, AXS-02, AXS-05,
AXS-06, AXS-07, and AXS-09. 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), a Phase 2 trial
in Major Depressive Disorder (MDD), and a Phase 2 trial in smoking
cessation. AXS-02 is currently in a Phase 3 trial in knee
osteoarthritis (OA) associated with bone marrow lesions (BMLs) with
an additional Phase 3 trial planned in chronic low back pain (CLBP)
associated with Modic changes (MCs). AXS-07 is being developed for
the acute treatment of migraine. AXS-06 is being developed for the
treatment of osteoarthritis and rheumatoid arthritis and for the
reduction of the risk of NSAID-associated gastric ulcers. AXS-02,
AXS-05, AXS-06, AXS-07, and AXS-09 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, interim
analyses and completion of the trials; the timing of and our
ability to obtain and maintain U.S. Food and Drug Administration or
other regulatory authority approval of, or other action with
respect to, our product candidates; 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; 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. 25 Broadway, 9th
Floor New York, NY 10004 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
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