Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in the American Journal of Psychiatry

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In this study, AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared to the active comparator bupropion

NEW YORK, May 18, 2022 /PRNewswire/ — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the release of results from the pivotal phase 2 clinical study of the ASCEND trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). AXS-05 is a new oral and investigational N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity. The article, “Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized, Double-Blind, Controlled Trial,” was published today in The American Journal of Psychiatry and is available in full here.

(PRNewsfoto/Axsome Therapeutics Inc)

“Major depressive disorder is widespread, debilitating and life-threatening. There is an urgent need for new, effective and well-tolerated mechanical treatments,” said Dan IosifescuMD, Professor of Psychiatry at New York University School of Medicine, director of the clinical research division of the Nathan Kline Institute for Psychiatric Research and co-author of the publication. “Due to its novel mechanism of action targeting glutamate and sigma-1 receptors, and its robust antidepressant efficacy demonstrated in this study, AXS-05 has the potential to become an important and very useful new treatment for patients. suffering from major depressive disorder.

“We are very pleased with the publication of the results of the ASCEND trial in The American Journal of Psychiatrythe most read psychiatric journal in the world1,” mentioned Herriot Tabuteau, MD, CEO of Axsome. “ASCEND is one of the pivotal efficacy trials that forms the basis of our NDA for AXS-05 in depression, which is currently under review by the FDA. Axsome is in a position to move quickly to put this product available to patients as soon as possible, should it be approved.”

The ASCEND trial evaluated the efficacy and safety of AXS-05 versus bupropion, an active comparator, in patients with MDD. A total of 80 patients with a diagnosis of moderate to severe MDD, confirmed by an independent clinical evaluator, were randomized to receive AXS-05 (dextromethorphan tablet 45 mg/bupropion tablet 105 mg) (n=43) or bupropion (105 mg tablet) (n=37), once daily for the first 3 days and twice daily thereafter, for a total of 6 weeks. The primary endpoint was the overall treatment effect on Montgomery-Åsberg Depression Rating Scale (MADRS) score (mean change from baseline for weeks 1-6).

In the trial, AXS-05 demonstrated rapid, substantial, and statistically significant improvement in depressive symptoms and remission induction compared to bupropion. The mean change from baseline in the MADRS score during weeks 1 to 6 was significantly greater with the AXS-05 than with bupropion (-13.7 points versus -8.8 points; mean difference in least squares = -4.9; p

AXS-05 was generally well tolerated in the trial. The most common adverse events with AXS-05 were dizziness, nausea, dry mouth, loss of appetite, and anxiety. AXS-05 was not associated with psychotomimetic effects, weight gain, or sexual dysfunction.

The article was published online today in The American Journal of Psychiatry before the next corresponding printed issue.

About the AXS-05

AXS-05 (dextromethorphan-bupropion) is a novel, patent-protected, investigational oral NMDA receptor antagonist with multimodal activity in development for the treatment of major depressive disorder and other central nervous system disorders ( CNS). AXS-05 uses a proprietary formulation and dose of dextromethorphan and bupropion, along with Axsome’s metabolic inhibition technology, to modulate component delivery. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning that it works differently from currently approved oral therapies for major depression. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan and is a norepinephrine and dopamine reuptake inhibitor. AXS-05 is currently covered by over 100 issued U.S. and international patents, with expiration dates through 2040. AXS-05 has received Breakthrough Therapy Designations from the FDA for the treatment of MDD and for the treatment of the agitation of Alzheimer’s disease. A New Drug Application (NDA) for AXS-05 for the treatment of major depressive disorder is under review by the FDA. AXS-05 is not FDA approved.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company that develops and delivers novel therapies for CNS conditions that have limited treatment options. Through the 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 significantly improve the lives of patients and provide new treatment options for physicians. For more information, please visit the company’s website at axsome.com. The Company may occasionally release material, non-public information on the Company’s website.

Forward-looking statements

Certain matters addressed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts”, “believes”, “potential”, “continues”, “estimates”, “anticipates”, “expects”, “plans”, “has ‘intent to’, ‘may, ‘could’, ‘might’, ‘shall’, ‘should’ or other words that convey uncertainty of future events or results to identify these forward-looking statements. In particular, the Company statements regarding trends and potential future results are examples of such forward-looking statements. Forward-looking statements involve risks and uncertainties, including, but not limited to, the continued commercial success of our newly acquired Sunosi product. the success, timing and cost of our ongoing clinical trials and planned clinical trials for our current product candidates, including statements regarding the timing of initiation, rate of recruitment and completion of trials (including our ability to fully finance our disclosed clinical trials, which assumes no material changes to our currently projected expenditures), futility analyzes and the receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or the type of studies or nature of results necessary to support the filing of an NDA for one of our current product candidates; our ability to fund additional clinical trials to further advance our product candidates; the timing and our ability to obtain and maintain FDA or other regulatory approval or other action with respect to our product candidates (including, but not limited to, whether potential filing issues or issues identified by the FDA during substantive review may impact the potential approval of the Company’s NDA submission for AXS-05 in the MDD or the timing of such approval; if the issues identified by the FDA in the Full Response letter may impact the Company’s potential NDA approval of AXS-07 for the acute treatment of migraine in adults with or without aura, in accordance with our special protocol. evaluation for the MOMENTUM clinical trial; the potential of the ASCEND clinical trial, combined with the results of the GEMINI clinical trial, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and to accelerate its calendar development and its commercial path with patients; the Company’s ability to successfully defend its intellectual strategy to operate or obtain the necessary licenses at a cost acceptable to the Company, if applicable; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s licensing agreements; market acceptance of the Company’s product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and for the commercial launch of its product candidates by the Company, and the potential impact on the Company’s anticipated cash flow; unforeseen circumstances or other disruptions to normal business operations resulting from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, beyond the Company’s control. The factors discussed herein could cause actual results and developments to differ materially from those expressed or implied by such statements. Forward-looking statements speak 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 circumstances.

Contact Axsome:

Marc Jacobson
CEO
Axsome Therapeutics, Inc.
22 Cortlandt Street16and Stage
New York, NY 10007
Tel: 212-332-3243
Email: [email protected]
www.axsome.com

References

1. American Psychiatric Association. About the American Journal of Psychiatry. Psychiatry online. 2022. https://ajp.psychiatryonline.org/about

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SOURCE Axsome Therapeutics Inc

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