Edgewise Therapeutics to Present on Sevasemten for the Treatment of Becker Muscular Dystrophy at the 2025 MDA Clinical and Scientific Conference
Edgewise Therapeutics (Nasdaq: EWTX) will present data on sevasemten, their first-in-class oral fast skeletal myosin inhibitor for Becker muscular dystrophy (BMD), at the MDA Clinical and Scientific Conference in Dallas from March 16-19, 2025.
The company will host an Industry Forum featuring Dr. Craig M. McDonald and Michael Voto, Jr. discussing BMD patient experiences and clinical advancements. Dr. McDonald will present the CANYON trial results showing sevasemten's effectiveness in reducing muscle damage biomarkers and stabilizing function in BMD patients.
The presentation includes five scientific posters covering:
- North Star Ambulatory Assessment predictions in BMD
- Two-year sevasemten treatment outcomes
- BMD skeletal phenotype analysis
- EDG-4131 myosin inhibitor results in BMD model mice
- Sevasemten's impact on muscle injury markers in the CANYON Phase II trial
Edgewise Therapeutics (Nasdaq: EWTX) presenterà dati su sevasemten, il loro inibitore orale di miocina a rapida azione di prima classe per la distrofia muscolare di Becker (BMD), alla Conferenza Clinica e Scientifica MDA che si terrà a Dallas dal 16 al 19 marzo 2025.
L'azienda ospiterà un Forum Industriale con il Dr. Craig M. McDonald e Michael Voto, Jr., che discuteranno delle esperienze dei pazienti BMD e dei progressi clinici. Il Dr. McDonald presenterà i risultati dello studio CANYON che mostrano l'efficacia di sevasemten nel ridurre i biomarcatori di danno muscolare e stabilizzare la funzione nei pazienti con BMD.
La presentazione include cinque manifestazioni scientifiche che coprono:
- Previsioni della North Star Ambulatory Assessment nella BMD
- Risultati del trattamento con sevasemten dopo due anni
- Analisi del fenotipo scheletrico della BMD
- Risultati dell'inibitore di miocina EDG-4131 in topi modello di BMD
- Impatto di sevasemten sui marcatori di danno muscolare nello studio di fase II CANYON
Edgewise Therapeutics (Nasdaq: EWTX) presentará datos sobre sevasemten, su inhibidor de miosina esquelética rápida por vía oral de primera clase para la distrofia muscular de Becker (BMD), en la Conferencia Clínica y Científica de la MDA que se llevará a cabo en Dallas del 16 al 19 de marzo de 2025.
La compañía organizará un Foro de la Industria con el Dr. Craig M. McDonald y Michael Voto, Jr., quienes discutirán las experiencias de los pacientes con BMD y los avances clínicos. El Dr. McDonald presentará los resultados del ensayo CANYON que muestran la efectividad de sevasemten en la reducción de biomarcadores de daño muscular y la estabilización de la función en pacientes con BMD.
La presentación incluye cinco pósteres científicos que abarcan:
- Predicciones de la Evaluación Ambulatoria North Star en BMD
- Resultados del tratamiento con sevasemten a dos años
- Análisis del fenotipo esquelético de BMD
- Resultados del inhibidor de miosina EDG-4131 en ratones modelo de BMD
- Impacto de sevasemten en los marcadores de lesión muscular en el ensayo de fase II CANYON
엣지와이즈 테라퓨틱스 (Nasdaq: EWTX)는 세바셈텐, 그들의 최초의 경구용 빠른 골격 미오신 억제제를 베커 근육 위축증 (BMD)에 대해 2025년 3월 16일부터 19일까지 달라스에서 열리는 MDA 임상 및 과학 회의에서 발표할 예정입니다.
회사는 Dr. Craig M. McDonald과 Michael Voto, Jr.가 BMD 환자의 경험과 임상 발전에 대해 논의하는 산업 포럼을 주최할 것입니다. McDonald 박사는 세바셈텐이 BMD 환자의 근육 손상 바이오마커를 줄이고 기능을 안정화하는 데 효과적이라는 것을 보여주는 CANYON 시험 결과를 발표할 것입니다.
발표에는 다음을 포함한 다섯 개의 과학 포스터가 포함됩니다:
- BMD에서의 노스 스타 외래 평가 예측
- 세바셈텐 치료 결과 2년
- BMD의 골격 표현형 분석
- BMD 모델 쥐에서 EDG-4131 미오신 억제제 결과
- CANYON 2상 시험에서 세바셈텐의 근육 손상 마커에 대한 영향
Edgewise Therapeutics (Nasdaq: EWTX) présentera des données sur sevasemten, leur inhibiteur oral de myosine squelettique rapide de première classe pour la dystrophie musculaire de Becker (BMD), lors de la Conférence Clinique et Scientifique de la MDA qui se tiendra à Dallas du 16 au 19 mars 2025.
La société organisera un Forum de l'Industrie avec le Dr Craig M. McDonald et Michael Voto, Jr., qui discuteront des expériences des patients atteints de BMD et des avancées cliniques. Le Dr McDonald présentera les résultats de l'essai CANYON montrant l'efficacité de sevasemten à réduire les biomarqueurs de dommages musculaires et à stabiliser la fonction chez les patients atteints de BMD.
La présentation comprend cinq affiches scientifiques couvrant :
- Prévisions de l'évaluation ambulatoire North Star dans la BMD
- Résultats du traitement par sevasemten après deux ans
- Analyse du phénotype squelettique de la BMD
- Résultats de l'inhibiteur de myosine EDG-4131 chez des souris modèles de BMD
- Impact de sevasemten sur les marqueurs de lésions musculaires dans l'essai de phase II CANYON
Edgewise Therapeutics (Nasdaq: EWTX) wird Daten zu sevasemten, ihrem ersten oralen Inhibitor der schnellen Skelettmiosin für die Becker-Muskeldystrophie (BMD), auf der MDA Klinischen und Wissenschaftlichen Konferenz in Dallas vom 16. bis 19. März 2025 präsentieren.
Das Unternehmen wird ein Branchenforum mit Dr. Craig M. McDonald und Michael Voto, Jr. veranstalten, die über die Erfahrungen von BMD-Patienten und klinische Fortschritte diskutieren. Dr. McDonald wird die Ergebnisse der CANYON-Studie präsentieren, die die Wirksamkeit von sevasemten bei der Reduzierung von Biomarkern für Muskelschäden und der Stabilisierung der Funktion bei BMD-Patienten zeigt.
Die Präsentation umfasst fünf wissenschaftliche Poster zu:
- Vorhersagen der North Star Ambulatory Assessment bei BMD
- Zwei-Jahres-Ergebnisse der Behandlung mit sevasemten
- Analyse des skeletalen Phänotyps bei BMD
- Ergebnisse des EDG-4131-Miosin-Inhibitors bei BMD-Modellmäusen
- Einfluss von sevasemten auf Muskelschadenmarker in der CANYON-Phase-II-Studie
- None.
- None.
– Company to host an Industry Forum to discuss the lived experience of Becker and clinical advancements featuring a leading neuromuscular disease expert and a patient advocate –
Details of the Edgewise presentations at MDA:
Edgewise Industry Forum
Edgewise is sponsoring an Industry Forum, “Spotlight on Becker muscular dystrophy: Understanding the lived experience of Becker and clinical advancements with a novel agent.” Only conference attendees can register for the forum.
Title: Shedding light on the lived experience of Becker muscular dystrophy
Presenter: Michael Voto, Jr.
Title: The natural history of Becker and clinical advancements with a novel agent
Presenter: Craig M. McDonald, M.D., Distinguished Professor and Chair at the UC Davis Health Department of Physical Medicine and Rehabilitation, and a Principal Investigator in CANYON and GRAND CANYON
Date: Tuesday, March 18, 2025, at 12 pm CT
Oral Presentation
Title: CANYON trial results: Sevasemten, an investigational fast skeletal myosin inhibitor, reduced muscle damage biomarkers and stabilized function in BMD
Presenter: Dr. McDonald
Date: Wednesday, March 19, 2025, 10:30-10:45 am CT
Scientific Posters
Title: P10: Prediction of North Star Ambulatory Assessment trajectories in Becker muscular dystrophy: Model development and validation
Title: P11: Two-year sevasemten treatment outcomes in Becker muscular dystrophy compared to natural history controls for the North Star Ambulatory Assessment
Title: P12: The skeletal phenotype in Becker muscular dystrophy: The under-studied cousin of Duchenne
Title: P19: Myosin inhibitor EDG-4131 improves pathophysiology and molecular pathology in BMD model mice
Title: LB432 Improved plasma signature of contraction-induced muscle injury with sevasemten in Becker muscular dystrophy in the CANYON Phase II trial
A companion poster presentation will be available for Dr. McDonald’s presentation (poster #O78). Posters will be showcased during the Poster and Networking Reception in the Trinity Exhibit Hall from March 16-18, 2025, 6 – 8 PM CT. The full MDA 2025 Conference program is available here: https://mdaconference.org.
The Edgewise presentation and posters will be available on the Edgewise website when they are presented.
About Sevasemten
Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect muscle against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne. Sevasemten presents a novel mechanism of action designed to selectively limit the exaggerated muscle damage caused by the absence or loss of functional dystrophin. By minimizing the progressive muscle damage that leads to functional impairment, sevasemten has the potential to benefit a broad range of patients suffering from debilitating neuromuscular disorders. Its unique mechanism of action provides the potential to establish sevasemten as a foundational therapy in dystrophinopathies, either as a single agent therapy or in combination with available therapies and those in development.
Sevasemten has achieved notable regulatory milestones by securing FDA Orphan Drug Designation for the treatment of Becker and Duchenne, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne, and Fast Track designations for the treatment of Becker and Duchenne. Further, sevasemten secured the EMA Orphan Drug Designations for the treatment of Becker and Duchenne.
For more information on Edgewise’s clinical trials https://edgewisetx.com/clinical-trials.
About Edgewise Therapeutics
Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company’s deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250311572254/en/
Edgewise Contacts
Investors:
Michael Carruthers, Chief Financial Officer
ir@edgewisetx.com
Media:
Maureen Franco, VP Corporate Communications
media@edgewisetx.com
Source: Edgewise Therapeutics
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