Axsome Therapeutics Presents Data from Multiple Programs at Sleep Europe 2024

Rhea-AI Summary

Axsome Therapeutics (NASDAQ: AXSM) announced seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society. The presentations include data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey on unmet needs in type 1 narcolepsy, and previously reported data on solriamfetol showing improvement in cognitive function in patients with excessive daytime sleepiness associated with OSA and narcolepsy.

The presentations cover various aspects of sleep disorders, including treatment outcomes, symptom burden, quality of life, and cognitive effects. Notable presentations include topline results from the SYMPHONY trial, real-world use of solriamfetol in patients with anxiety or depression, and effects of solriamfetol on cognition in obstructive sleep apnea patients with excessive daytime sleepiness.

Positive

• Presentation of Phase 3 SYMPHONY trial results for AXS-12 in narcolepsy
• Multiple presentations showcasing Axsome's growing CNS portfolio
• Data demonstrating solriamfetol's improvement in cognitive function for patients with excessive daytime sleepiness

Negative

• None.

Insights

Medical Research Analyst

The presentations at Sleep Europe 2024 showcase Axsome Therapeutics' progress in addressing unmet needs in sleep disorders, particularly narcolepsy and obstructive sleep apnea (OSA). Key highlights include:

• Topline results from the Phase 3 SYMPHONY trial of AXS-12 for narcolepsy treatment, indicating potential advancement towards regulatory submission.
• The CRESCENDO survey results, which likely provide valuable insights into the patient experience and unmet needs in narcolepsy type 1, potentially guiding future drug development and marketing strategies.
• Multiple presentations on solriamfetol, demonstrating its effects on wakefulness, cognitive function and real-world use in patients with excessive daytime sleepiness (EDS) associated with narcolepsy and OSA.

These data presentations strengthen Axsome's position in the CNS and sleep disorder markets. The company is showing a comprehensive approach to sleep disorders, addressing both treatment efficacy and quality of life aspects. This could potentially lead to increased market share and revenue growth if these therapies prove successful in further studies or gain regulatory approvals.

Seven presentations highlight the Company’s growing CNS portfolio and commitment to improving treatment outcomes for patients with sleep disorders

NEW YORK, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, being held September 24-27, 2024, in Seville, Spain. Featured presentations include data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey underscoring the unmet needs of patients with type 1 narcolepsy, and previously reported data on solriamfetol demonstrating improvement in cognitive function in patients with excessive daytime sleepiness (EDS) associated with OSA and narcolepsy.

Details for the presentations are as follows:

AXS-12:

Title: AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial
Poster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CEST
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY, USA
Poster Number: P254

Title: CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1
Poster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CEST
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY, USA
Poster Number: P265

Solriamfetol:

Title: Solriamfetol and Maintenance of Wakefulness Outcomes in Patients with Narcolepsy and Obstructive Sleep Apnea
Oral Presentation Date and Time: Tuesday, September 24, 9:55 - 10:01 a.m. CEST
Poster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CEST
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY, USA
Poster Number: P475

Title: Effects of Solriamfetol on Cognition in Patients with Excessive Daytime Sleepiness Associated with Narcolepsy
Poster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CEST
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: P197

Title: Real-world Use of Solriamfetol for Excessive Daytime Sleepiness in Patients Reporting Anxiety or Depression
Poster Presentation Date and Time: Friday, September 27, 10:45 a.m. - 1:30 p.m. CEST
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: P198

Title: SURWEY: Treatment of Excessive Daytime Sleepiness with Solriamfetol: Initiation, Titration, and Outcome
Poster Presentation Date and Time: Thursday, September 26, 12:00 - 1:30 p.m. and 5:30 – 6:45 p.m. CEST
Lead Author: Samantha Floam, DMD, Axsome Therapeutics
Poster Number: P799

Title: Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea with Excessive Daytime Sleepiness and Impaired Cognition
Poster Presentation Date and Time: Friday, September 27, 10:45 a.m. - 1:30 p.m. CEST
Lead Author: Hans Van Dongen, PhD, Professor at Washington State University
Poster Number: P1248

About Axsome Therapeutics

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 www.axsome.com.

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 continued commercial success of the Company’s Sunosi® and Auvelity® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s 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 the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s 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 the Company’s 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; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, 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.

Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com

Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com

FAQ

What are the key presentations by Axsome Therapeutics (AXSM) at Sleep Europe 2024?

Axsome Therapeutics is presenting seven studies at Sleep Europe 2024, including data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey on type 1 narcolepsy, and data on solriamfetol's effects on cognitive function in patients with excessive daytime sleepiness.

What is the focus of the SYMPHONY Phase 3 trial presented by Axsome Therapeutics (AXSM)?

The SYMPHONY Phase 3 trial focuses on AXS-12 for the treatment of narcolepsy. Topline results from this trial will be presented at Sleep Europe 2024.

How does solriamfetol, developed by Axsome Therapeutics (AXSM), affect cognitive function in sleep disorder patients?

According to the presentations, solriamfetol demonstrates improvement in cognitive function for patients with excessive daytime sleepiness associated with obstructive sleep apnea (OSA) and narcolepsy.

What is the CRESCENDO survey presented by Axsome Therapeutics (AXSM) about?

The CRESCENDO survey, presented by Axsome Therapeutics, focuses on the symptom burden and quality of life in patients with narcolepsy type 1, highlighting unmet needs in this patient population.