Axsome Therapeutics to Present New Data for AXS-05 in Major Depressive Disorder at the 33rd European College of Neuropsychopharmacology Congress

Rhea-AI Summary

Axsome Therapeutics (NASDAQ: AXSM) announced the presentation of clinical data on AXS-05 for major depressive disorder (MDD) at the 33rd Congress of the European College of Neuropsychopharmacology (ECNP), held virtually from September 12-15, 2020. AXS-05 is an investigational oral NMDA receptor antagonist designed for MDD treatment. The poster presentation, titled 'Efficacy and safety of AXS-05', will feature insights from the Phase 3 GEMINI trial. AXS-05 is under development for multiple CNS disorders and has received FDA Breakthrough Therapy and Fast Track designations.

NEW YORK, Sept. 10, 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 clinical data on AXS-05 in the treatment of major depressive disorder (MDD) at the 33^rd Congress of the European College of Neuropsychopharmacology (ECNP), to be held virtually, September 12-15. AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist. The poster presentation will highlight new insights from the Phase 3 GEMINI trial.

Details of the presentation are as follows:

Title: Efficacy and safety of AXS-05, an oral, NMDA receptor antagonist with multimodal activity in major depressive disorder
Poster Number: P.327
Date: Saturday September 12 – Tuesday September 15, 2020
Location: The 2020 ECNP Virtual Congress will be available to everyone. Attendees will be asked to register to access the meeting platform at: https://www.ecnp.eu/Congress2020/ECNPcongress/registration/Registration.

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

About AXS-05

AXS-05 is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder, Alzheimer’s disease agitation, and other central nervous system (CNS) disorders. AXS-05 consists of a proprietary formulation and dose of dextromethorphan and bupropion and utilizes Axsome’s metabolic inhibition technology. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, a sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, a nicotinic acetylcholine receptor antagonist, and an inhibitor of microglial activation. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 42 issued U.S. and international patents which provide protection out to 2034. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for major depressive disorder, Fast Track designation for treatment resistant depression, and Breakthrough Therapy and Fast Track designations for Alzheimer’s disease agitation. AXS-05 is 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 a 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 Street, 16^th Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com  
www.axsome.com 

FAQ

What is AXS-05 and its relevance to AXSM?

AXS-05 is an investigational oral medication by Axsome Therapeutics intended to treat major depressive disorder (MDD) and has received FDA Breakthrough designations.

When will Axsome present data on AXS-05?

Axsome will present data on AXS-05 at the ECNP Congress from September 12 to 15, 2020.

What trial data will be discussed regarding AXS-05?

The presentation will highlight new findings from the Phase 3 GEMINI trial related to the efficacy and safety of AXS-05.

Where can I access the presentation on AXS-05?

The presentation will be available on Axsome's website shortly after the ECNP meeting concludes.

What designations has AXS-05 received from the FDA?

AXS-05 has received FDA Breakthrough Therapy designation for major depressive disorder and Fast Track designation for treatment-resistant depression.