Axsome Therapeutics Presents Data from Multiple Programs at Sleep Europe 2024
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.
Axsome Therapeutics (NASDAQ: AXSM) ha annunciato sette presentazioni su AXS-12 e solriamfetol al Sleep Europe 2024, il 27° Congresso della Società Europea di Ricerca sul Sonno. Le presentazioni includono dati dal trial di Fase 3 SYMPHONY su AXS-12 nella narcolessia, risultati dal sondaggio CRESCENDO sui bisogni insoddisfatti nella narcolessia di tipo 1, e dati precedentemente riportati su solriamfetol che mostrano un miglioramento nella funzione cognitiva nei pazienti con eccessiva sonnolenza diurna associata a OSA e narcolessia.
Le presentazioni coprono vari aspetti dei disturbi del sonno, tra cui i risultati dei trattamenti, il carico dei sintomi, la qualità della vita e gli effetti cognitivi. Presentazioni degne di nota includono i risultati principali del trial SYMPHONY, l'uso reale di solriamfetol nei pazienti con ansia o depressione, e gli effetti di solriamfetol sulla cognizione nei pazienti con apnea ostruttiva del sonno accompagnata da eccessiva sonnolenza diurna.
Axsome Therapeutics (NASDAQ: AXSM) anunció siete presentaciones sobre AXS-12 y solriamfetol en Sleep Europe 2024, el 27º Congreso de la Sociedad Europea de Investigación del Sueño. Las presentaciones incluyen datos del ensayo de Fase 3 SYMPHONY de AXS-12 en narcolepsia, hallazgos de la encuesta CRESCENDO sobre necesidades no satisfechas en la narcolepsia de tipo 1, y datos previamente informados sobre solriamfetol que muestran mejora en la función cognitiva en pacientes con somnolencia diurna excesiva asociada a OSA y narcolepsia.
Las presentaciones cubren varios aspectos de los trastornos del sueño, incluidos los resultados del tratamiento, la carga de síntomas, la calidad de vida y los efectos cognitivos. Presentaciones notables incluyen resultados generales del ensayo SYMPHONY, el uso en la vida real de solriamfetol en pacientes con ansiedad o depresión, y los efectos de solriamfetol sobre la cognición en pacientes con apnea del sueño obstructiva y somnolencia diurna excesiva.
Axsome Therapeutics (NASDAQ: AXSM)는 Sleep Europe 2024, 제27회 유럽 수면 연구 학회에서 AXS-12 및 solriamfetol에 대한 일곱 개의 발표를 발표했습니다. 발표 내용에는 나르콜렙시아에 대한 AXS-12의 3상 SYMPHONY 시험 데이터, 1형 나르콜렙시아의 충족되지 않은 요구에 대한 CRESCENDO 환자 설문조사 결과, 그리고 OSA와 나르콜렙시아와 관련된 과도한 주간 졸림증 환자의 인지 기능 개선을 보여주는 solriamfetol의 이전 보고된 데이터가 포함되어 있습니다.
발표는 치료 결과, 증상 부담, 삶의 질 및 인지적 효과를 포함한 수면 장애의 다양한 측면을 다룹니다. 주목할 만한 발표로는 SYMPHONY 시험의 주요 결과, 불안이나 우울증이 있는 환자에서 solriamfetol의 실제 사용, 그리고 과도한 주간 졸림증이 있는 폐쇄성 수면 무호흡 환자에서의 solriamfetol의 인지에 대한 효과가 포함됩니다.
Axsome Therapeutics (NASDAQ: AXSM) a annoncé sept présentations sur AXS-12 et solriamfetol lors du Sleep Europe 2024, le 27ème Congrès de la Société Européenne de Recherche sur le Sommeil. Les présentations comprennent des données de l'essai de Phase 3 SYMPHONY sur AXS-12 dans la narcolepsie, des résultats de l'enquête CRESCENDO sur les besoins non satisfaits dans la narcolepsie de type 1, et des données précédemment rapportées sur solriamfetol montrant une amélioration de la fonction cognitive chez les patients présentant une somnolence diurne excessive associée à l'OSA et à la narcolepsie.
Les présentations couvrent différents aspects des troubles du sommeil, y compris les résultats des traitements, le fardeau des symptômes, la qualité de vie et les effets cognitifs. Parmi les présentations notables, on trouve les résultats globaux de l'essai SYMPHONY, l'utilisation réelle de solriamfetol chez des patients souffrant d'anxiété ou de dépression, et les effets de solriamfetol sur la cognition chez les patients atteints d'apnée obstructive du sommeil avec somnolence diurne excessive.
Axsome Therapeutics (NASDAQ: AXSM) hat sieben Präsentationen zu AXS-12 und Solriamfetol auf dem Sleep Europe 2024, dem 27. Kongress der Europäischen Gesellschaft für Schlafmedizin, angekündigt. Zu den Präsentationen gehören Daten aus der SYMPHONY Phase 3 Studie zu AXS-12 bei Narkolepsie, Ergebnisse aus der CRESCENDO-Patientenbefragung zu unerfüllten Bedürfnissen bei Narkolepsie Typ 1 und zuvor berichtete Daten zu Solriamfetol, die Verbesserungen in der kognitiven Funktion bei Patienten mit übermäßiger Tagesmüdigkeit im Zusammenhang mit OSA und Narkolepsie zeigen.
Die Präsentationen behandeln verschiedene Aspekte von Schlafstörungen, einschließlich Behandlungsergebnissen, Symptombelastung, Lebensqualität und kognitiven Effekten. Bemerkenswerte Präsentationen umfassen die Gesamtergebnisse der SYMPHONY-Studie, die realistische Anwendung von Solriamfetol bei Patienten mit Angst oder Depression sowie die Auswirkungen von Solriamfetol auf die Kognition bei Patienten mit obstruktiver Schlafapnoe und übermäßiger Tagesmüdigkeit.
- 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
- None.
Insights
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
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