Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol for the Treatment of Binge Eating Disorder
April 01 2024 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, announced the
initiation of the ENGAGE Phase 3 trial of solriamfetol, an
investigational treatment for binge eating disorder (BED) in
adults.
ENGAGE (Elucidating TAAR-1, Dopamine, and
Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a
Phase 3, randomized, double-blind, placebo-controlled, multicenter
trial to assess the efficacy and safety of solriamfetol for the
treatment of BED in adults. Approximately 450 patients will be
randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg)
or placebo for 12 weeks. The primary endpoint will be the change in
binge eating episodes. The first patient was screened in the ENGAGE
trial in March 2024.
About Binge Eating Disorder
Binge eating disorder (BED) is a serious,
chronic biologically based disorder characterized by recurrent
episodes of eating excessive amounts of food within a discrete
period of time while also feeling a lack of control over the
eating, distress about the bingeing, and without
weight-compensatory behaviors seen in bulimia nervosa, such as
purging.1 BED is the most common eating disorder, affecting an
estimated 2.8% of U.S. adults, or about 7 million, and it is 1.75
times more common in women.2
About Solriamfetol
Solriamfetol is a dopamine and norepinephrine
reuptake inhibitor and trace amine-associated receptor 1 (TAAR1)
agonist. Solriamfetol is not approved by the FDA for the treatment
of binge eating disorder.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for central
nervous system (CNS) conditions that have limited treatment
options. Through development of therapeutic options with novel
mechanisms of action, we are transforming the approach to treating
CNS conditions. At Axsome, we are committed to developing products
that meaningfully improve the lives of patients and provide new
therapeutic options for physicians. 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
continued commercial success of our Sunosi® and Auvelity® products
and the success of our efforts to obtain any additional
indication(s) with respect to solriamfetol and/or AXS-05; 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 revenues or expenses), futility
analyses and receipt of interim results, which are not necessarily
indicative of the final results of our ongoing clinical trials,
and/or data readouts, 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 statements
regarding the timing of any NDA submission; whether issues
identified by FDA in the complete response letter may impact the
potential approvability of the Company’s NDA for AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment for the MOMENTUM
clinical trial; 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 products and product
candidates, if approved; the Company’s anticipated capital
requirements, including the amount of capital required for the
continued commercialization of Sunosi and Auvelity and for the
Company’s commercial launch of its other product candidates, if
approved, and the potential impact on the Company’s anticipated
cash runway; unforeseen circumstances or other disruptions to
normal business operations arising from or related to geo-political
conflicts or a global pandemic 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 Contacts:
Investors:Mark JacobsonChief Operating OfficerAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
Media:Darren OplandDirector, Corporate CommunicationsAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com
References:
- American Psychiatric Association. Diagnostic and Statistical
Manual of Mental Disorders, 5th ed. Arlington, VA: American
Psychiatric Association; 2013.
- J. I. Hudson, E. Hiripi, H. G. Pope, and R. C. Kessler, “The
Prevalence and Correlates of Eating Disorders in the National
Comorbidity Survey Replication,” Biol. Psychiatry, vol. 61, no. 3,
pp. 348–358, Feb. 2007, doi: 10.1016/j.biopsych.2006.03.040.
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