Edgewise Therapeutics to Present on Sevasemten (EDG-5506) for Becker Muscular Dystrophy (Becker) at the 29th International Annual Congress of the World Muscle Society
Edgewise Therapeutics (Nasdaq: EWTX) announced its participation at the 29th International Annual Congress of the World Muscle Society in Prague, October 8-12, 2024. The company will present an industry-sponsored symposium and seven scientific posters highlighting the effects of sevasemten in individuals with Becker muscular dystrophy.
The symposium, titled 'Understanding disease progression and a potential novel agent to protect muscle,' will feature key opinion leaders and discuss positive two-year topline results from the ARCH trial. The scientific posters will cover topics such as reduced muscle damage biomarkers, functional stabilization, and proteomic responses to sevasemten in Becker muscular dystrophy patients.
Sevasemten is an orally administered small molecule designed to prevent contraction-induced muscle damage in muscular dystrophies. The presentations will provide insights into biomarker and functional endpoints being studied in the CANYON Phase 2 trial.
Edgewise Therapeutics (Nasdaq: EWTX) ha annunciato la sua partecipazione al 29° Congresso Internazionale Annuale della World Muscle Society che si terrà a Praga, dall'8 al 12 ottobre 2024. L'azienda presenterà un simposio sponsorizzato dall'industria e sette poster scientifici che evidenziano gli effetti di sevasemten su individui con distrofia muscolare di Becker.
Il simposio, intitolato 'Comprendere la progressione della malattia e un potenziale nuovo agente per proteggere i muscoli', ospiterà leader di opinione e discuterà i positivi risultati preliminari a due anni provenienti dal trial ARCH. I poster scientifici tratteranno argomenti come i biomarker di danno muscolare ridotto, la stabilizzazione funzionale e le risposte proteomiche a sevasemten nei pazienti con distrofia muscolare di Becker.
Sevasemten è una piccola molecola somministrata oralmente progettata per prevenire i danni muscolari indotti dalla contrazione nelle distrofie muscolari. Le presentazioni forniranno approfondimenti sui biomarker e sugli obiettivi funzionali in fase di studio nel trial di Fase 2 CANYON.
Edgewise Therapeutics (Nasdaq: EWTX) anunció su participación en el 29º Congreso Internacional Anual de la World Muscle Society en Praga, del 8 al 12 de octubre de 2024. La empresa presentará un simposio patrocinado por la industria y siete posters científicos que destacan los efectos de sevasemten en individuos con distrofia muscular de Becker.
El simposio, titulado 'Entendiendo la progresión de la enfermedad y un posible nuevo agente para proteger el músculo', contará con líderes de opinión y discutirá los positivos resultados preliminares a dos años del ensayo ARCH. Los posters científicos cubrirán temas como los biomarcadores de daño muscular reducidos, la estabilización funcional y las respuestas proteómicas a sevasemten en pacientes con distrofia muscular de Becker.
Sevasemten es una pequeña molécula administrada por vía oral diseñada para prevenir el daño muscular inducido por contracción en distrofias musculares. Las presentaciones proporcionarán información sobre los biomarcadores y los puntos finales funcionales que se están estudiando en el ensayo de Fase 2 CANYON.
Edgewise Therapeutics (Nasdaq: EWTX)는 2024년 10월 8일부터 12일까지 프라하에서 열리는 제29회 세계근육학회 국제연례회의에 참석한다고 발표했습니다. 이 회사는 산업 스폰서가 주최하는 심포지엄과 베커 근육형성증 환자에서 세바셈텐의 효과를 강조한 7개의 과학 포스터를 발표할 예정입니다.
이 심포지엄의 제목은 '질병 진행 이해 및 근육 보호를 위한 잠재적 신약'으로, 주요 의견 리더들이 참여하여 ARCH 시험의 2년간 긍정적인 초기 결과를 논의합니다. 과학 포스터는 감소된 근육 손상 바이오마커, 기능적 안정성 및 베커 근육형성증 환자에서 세바셈텐에 대한 단백질 반응과 같은 주제를 다룰 것입니다.
세바셈텐은 근육형성증에서 수축 유도 근육 손상을 예방하도록 설계된 경구 투여 소분자로, 발표 내용은 CANYON 2상 시험에서 연구되고 있는 바이오마커 및 기능적 최종점에 대한 통찰을 제공할 것입니다.
Edgewise Therapeutics (Nasdaq: EWTX) a annoncé sa participation au 29ème Congrès International Annuel de la World Muscle Society qui se déroulera à Prague, du 8 au 12 octobre 2024. L'entreprise présentera un symposium sponsorisé par l'industrie et sept affiches scientifiques mettant en lumière les effets de sevasemten chez les individus atteints de dystrophie musculaire de Becker.
Le symposium, intitulé 'Comprendre la progression de la maladie et un potentiel nouvel agent pour protéger les muscles', mettra en avant des leaders d'opinion et discutera des résultats positifs préliminaires sur deux ans issus de l'
Sevasemten est une petite molécule administrée par voie orale, conçue pour prévenir les dommages musculaires induits par la contraction dans les dystrophies musculaires. Les présentations fourniront des aperçus sur les biomarqueurs et les critères fonctionnels étudiés dans l'
Edgewise Therapeutics (Nasdaq: EWTX) gab seine Teilnahme an dem 29. Internationalen Jahreskongress der World Muscle Society in Prag vom 8. bis 12. Oktober 2024 bekannt. Das Unternehmen wird ein von der Industrie gesponsertes Symposium sowie sieben wissenschaftliche Poster präsentieren, die die Wirkungen von sevasemten bei Personen mit Becker-Muskeldystrophie hervorheben.
Das Symposium mit dem Titel 'Verstehen des Krankheitsverlaufs und eines potenziellen neuartigen Mittels zum Schutz der Muskulatur' wird führende Meinungsführer vorstellen und positive Ergebnisse aus dem ARCH-Versuch mit einem Zeitraum von zwei Jahren diskutieren. Die wissenschaftlichen Poster werden Themen wie reduzierte Biomarker für Muskelschäden, funktionale Stabilisierung und proteomische Reaktionen auf Sevasemten bei Patienten mit Becker-Muskeldystrophie behandeln.
Sevasemten ist ein oral verabreichtes kleines Molekül, das entwickelt wurde, um schädliche Muskelkontraktionen bei Muskeldystrophien zu verhindern. Die Präsentationen werden Erkenntnisse über Biomarker und funktionale Endpunkte bieten, die im CANYON Phase 2-Versuch untersucht werden.
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Details of the Edgewise symposium and scientific posters at WMS:
Edgewise Symposium with Key Opinion Leaders
Date: Tuesday, October 8, 2024, at 4:30 pm CEST
Title: Understanding disease progression and a potential novel agent to protect muscle
Presenters: Luca Bello, M.D., Ph.D, Associate Professor, Department of Neurosciences, DNS, University of
The symposium will also include discussion of the positive two-year topline results from the ARCH trial, an open label, single-center study assessing safety, tolerability, impact on muscle damage biomarkers, pharmacokinetics (PK) and functional measures with sevasemten in adults with Becker. Only registered conference attendees can register for the symposium.
Scientific Posters
Title: Sevasemten, a fast myosin inhibitor, in adults with Becker muscular dystrophy results in reduced muscle damage biomarkers and functional stabilization (351P)
Title: Rasch evaluation of North Star Ambulatory Assessment and North Star Assessment for Limb-Girdle Type Muscular Dystrophies in Becker muscular dystrophy (322P)
Title: Exploring the content validity of patient-reported outcome (PRO) measures to capture the patient experience of Becker Muscular Dystrophy (BMD) (339P)
Title: Comparison of short- and long-term proteomic response to the fast skeletal myosin inhibitor, sevasemten (EDG-5506), in Becker muscular dystrophy (BMD) (349P)
Title: Protein biomarkers of muscle injury exhibit differential reduction with subject age in adults with Becker muscular dystrophy (
Title: Post-exercise biomarkers of muscle injury are reduced by sevasemten, a fast myosin inhibitor, in adults with Becker muscular dystrophy (
Title: Clinical trial readiness in rare and underserved disease: learnings from community engagement and the lived experience in Becker muscular dystrophy (Becker) (708LPB)
All Edgewise posters are being presented on Friday, October 11, 2024, in Poster Session 4 (Forum Hall) from 3:45 to 4:45 pm CEST. The full WMS Congress program is available here.
The Edgewise symposium presentation and posters will be available on the Edgewise website.
About Sevasemten for Becker and Duchenne Muscular Dystrophies
Sevasemten is an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies 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.
In Becker, after completion of the two-year Phase 1 ARCH trial, the Company continues to advance sevasemten through the clinic with the Phase 2 CANYON trial, which is fully enrolled, evaluating safety and effects on function and biomarkers of muscle damage in adult males with Becker. The Company expects to report CANYON data in the fourth quarter of 2024. The CANYON trial has expanded to include an additional 120 adult participants in a pivotal cohort GRAND CANYON, which is currently enrolling in
In Duchenne, the Company is advancing its Phase 2 clinical trials, LYNX, assessing safety, pharmacokinetics and biomarkers of muscle damage, and FOX, which includes children and adolescents previously treated with gene therapy. The Company expects to report LYNX data in the fourth quarter of 2024. The Company will rely on LYNX data, along with data from the FOX trial of Duchenne children previously treated with gene therapy, to guide the design and powering of a Phase 3 trial in Duchenne, planned to be initiated in the first half of 2025.
For more information on Edgewise’s clinical trials https://edgewisetx.com/science-pipeline/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 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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding sevasemten; statements regarding the timing of reporting data (including the data from the CANYON trial and the LYNX trial); statements regarding Edgewise’s expectations relating to its clinical trials (including the CANYON trial, GRAND CANYON trial, LYNX trial and FOX trial); statements regarding the data from GRAND CANYON being able to support a marketing application; and statements regarding the commencement of trials (including the Phase 3 trial of sevasemten in Duchenne). Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with Edgewise’s limited operating history, its products being early in development and not having products approved for commercial sale; risks associated with Edgewise not having generated any revenue to date; Edgewise’s ability to achieve objectives relating to the discovery, development and commercialization of its product candidates, if approved; Edgewise’s need for substantial additional capital to finance its operations; Edgewise’s substantial dependence on the success of its sevasemten; Edgewise’s ability to develop and commercialize sevasemten and discover, develop and commercialize product candidates in future programs; risks related to Edgewise’s clinical trials of its product candidates not demonstrating safety and efficacy; risks related to Edgewise’s product candidates causing serious adverse events, toxicities or other undesirable side effects; the outcome of preclinical testing and early clinical trials not being predictive of the success of later clinical trials and the risks related to the results of Edgewise’s clinical trials not satisfying the requirements of regulatory authorities; delays or difficulties in the enrollment and/or maintenance of patients in clinical trials; risks related to failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim, topline and preliminary data from Edgewise’s clinical trials changing as more patient data becomes available; risks related to the regulatory approval processes being lengthy, time consuming and inherently unpredictable; risks related to regulatory authorities not accepting data from trials conducted in locations outside of their jurisdiction; risks relating to Edgewise’s ability to attract and retain highly skilled executive officers and employees; Edgewise’s ability to obtain and maintain intellectual property protection for its product candidates; Edgewise’s reliance on third parties; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Edgewise files from time to time with the
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Edgewise Contacts
Investors:
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ir@edgewisetx.com
Media:
Maureen Franco, VP Corporate Communications
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Source: Edgewise Therapeutics
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