Axsome Therapeutics to Present Data from the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy at the SLEEP 2020 Annual Meeting

Rhea-AI Summary

Axsome Therapeutics (AXSM) announced the presentation of efficacy and safety data for AXS-12, a novel treatment for narcolepsy, during the virtual 34th Annual SLEEP Meeting from August 27 to 30, 2020. AXS-12, a selective norepinephrine reuptake inhibitor, has received FDA Breakthrough Therapy and Orphan Drug designations. The trial results will be detailed in a poster titled Efficacy and Safety of AXS-12 in the Treatment of Narcolepsy, poster number 0739. Further information will be made available on Axsome's website post-presentation.

Positive

• AXS-12 has received FDA Breakthrough Therapy designation and Orphan Drug Designation for narcolepsy, indicating its potential significance in the market.
• The presentation of Phase 2 trial data at a prominent conference highlights the company's ongoing commitment to developing treatments for CNS disorders.

Negative

• None.

NEW YORK, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present efficacy and safety data from the CONCERT Phase 2 trial of AXS-12 in the treatment of narcolepsy at the 34th Annual SLEEP Meeting of the Associated Professional Sleep Societies (APSS). The meeting, which is a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), is being held virtually from August 27 to 30. AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy. Details of the poster presentation are as follows:

Session: New Treatments for Narcolepsy
Title: Efficacy and Safety of AXS-12 in the Treatment of Narcolepsy: Results from a Phase 2, Double-Blind, Placebo-Controlled, Crossover Trial
Poster Number: 0739
Date: Friday August 28 – Sunday August 30, 2020

A copy of the presentation will be available shortly after the meeting on Axsome’s website at www.axsome.com.

About AXS-12
AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and 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 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.

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 Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
22 Cortlandt, 16^th Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com

FAQ

What is AXS-12 and its significance for narcolepsy treatment?

AXS-12 is a novel norepinephrine reuptake inhibitor being developed by Axsome Therapeutics, with Breakthrough Therapy and Orphan Drug designations from the FDA.

When will the results of the AXS-12 trial be available?

The efficacy and safety data from the CONCERT Phase 2 trial of AXS-12 will be presented at the virtual SLEEP Meeting from August 27 to 30, 2020.

What does the Phase 2 trial for AXS-12 involve?

The Phase 2 trial is a double-blind, placebo-controlled, crossover trial assessing the efficacy and safety of AXS-12 in treating narcolepsy.

How can investors access the AXS-12 trial presentation?

A copy of the presentation will be available on Axsome's website shortly after the meeting concludes.

What is the potential market impact of AXS-12?

If successful, AXS-12 could address the unmet needs in narcolepsy treatment, potentially leading to significant market opportunities for Axsome Therapeutics.