NEW YORK, Nov. 14, 2018 (GLOBE NEWSWIRE) -- 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 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, investigational medicine, consisting of
dextromethorphan and bupropion, with glutamatergic, monoaminergic, and anti-inflammatory mechanisms. Topline results from the
ASCEND trial are expected early January 2019.
“We are excited to complete enrollment of the ASCEND trial, and we look forward to the upcoming results of this
study. ASCEND is evaluating the effect of AXS-05 as compared to bupropion on the symptoms of major depressive disorder,” said
Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We believe that the multiple mechanisms of action of AXS-05 may be
relevant to other CNS disorders. In addition to major depressive disorder, we are also evaluating AXS-05 in treatment resistant
depression with the ongoing STRIDE-1 Phase 3 trial, agitation associated with Alzheimer’s disease with the ongoing ADVANCE-1 Phase
2/3 trial, and smoking cessation with a Phase 2 trial that is being conducted under a research collaboration with Duke
University.”
About the ASCEND Study
ASCEND (Assessing Clinical Episodes in Depression) is a Phase 2, randomized, double-blind, 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 Institutes 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 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 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-07 is being developed for the acute
treatment of migraine. AXS-12 is being developed for the treatment of the symptoms of 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.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company 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 the Company’s ongoing clinical trials and anticipated clinical trials for its current
product candidates, including statements regarding the timing of initiation, interim analyses and completion of the trials,
futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s
ongoing clinical trials; the Company’s ability to fund additional clinical trials to continue the advancement of its product
candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory
authority approval of, or other action with respect to, its product candidates; the Company’s expected cash runway; 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
