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Edgewise Therapeutics to Present on Sevasemten for the Treatment of Becker Muscular Dystrophy at the 2025 MDA Clinical and Scientific Conference

Published 19 hours ago via Business Wire

– 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 –

Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the company will present data on sevasemten, an investigational orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage, at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. The conference will take place at the Hilton Anatole, Dallas, TX from March 16-19, 2025.

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.

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