Axsome Therapeutics Completes Patient Enrollment in the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy
October 21 2019 - 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 enrollment in the CONCERT
study, a Phase 2, randomized, double-blind, placebo-controlled,
crossover, trial of AXS-12 in patients with narcolepsy. AXS-12
(reboxetine) is a novel, oral, potent and highly selective
norepinephrine reuptake inhibitor for the treatment of narcolepsy.
Axsome remains on track to report topline results from CONCERT in
the fourth quarter of 2019.
About the CONCERT Trial
CONCERT (Clinical Outcomes in Narcolepsy and
Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2,
double-blind, randomized, placebo-controlled, crossover,
multicenter trial of AXS-12 in patients with narcolepsy. The study
will enroll approximately 20 patients, all of whom will be treated
with AXS-12 for three weeks, and with placebo for three weeks.
Eligible patients will be randomized to receive either AXS-12
followed by placebo, or placebo followed by AXS-12. Efficacy
assessments will include the frequency of cataplexy attacks and
measures of other symptoms of narcolepsy.
About Narcolepsy
Narcolepsy is a serious and debilitating
neurological condition that causes dysregulation of the sleep-wake
cycle and is characterized clinically by excessive daytime
sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis,
and disrupted nocturnal sleep. Narcolepsy afflicts an estimated
185,000 individuals in the U.S. Cataplexy is seen in an estimated
70% of narcolepsy patients and is a sudden reduction or loss of
muscle tone while a patient is awake, typically triggered by strong
emotions such as laughter, fear, anger, stress, or excitement.
Narcolepsy interferes with cognitive, psychological, and social
functioning, increases the risk of work- and driving-related
accidents, and is associated with a 1.5-fold higher mortality rate.
Depression is reported in up to 57% of patients.
About AXS-12
AXS-12 (reboxetine) is a novel, oral,
investigational medicine in development for the treatment of the
symptoms of narcolepsy. AXS-12 is a highly selective and potent
norepinephrine reuptake inhibitor. AXS-12 has been granted U.S.
Food and Drug Administration (FDA) Orphan Drug Designation for the
treatment of narcolepsy. AXS-12 is an investigational drug product
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. AXS-05, 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.
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 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, including the Company’s anticipated cash runway and
the Company’s current expectations regarding its plans for future
equity financings prior to the readout from its Phase 3 trials; 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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