– Company to host conference symposium to discuss its approach to protecting dystrophic muscle featuring key opinion leaders and 12-month results from the ARCH open label study of EDG-5506 in adults with Becker –

Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the Company will present on EDG-5506, an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, at the 28th International Annual Congress of the World Muscle Society (WMS). The conference will take place at the Charleston Convention Center in Charleston, South Carolina, from October 3-7, 2023.

Details of the Edgewise symposium and scientific posters at WMS:

Edgewise Symposium with Key Opinion Leaders

On Tuesday, October 3, 2023, at 4:30 pm ET, Edgewise will sponsor a symposium, “Becker Muscular Dystrophy Natural History and ARCH, an Open Label Study in Becker: Putting the Data in Context.” The symposium will feature presentations by Edgewise leadership and leading neuromuscular disease experts:

• Erik Niks, M.D., Ph.D., Neurologist, Leiden University Medical Center
  • Presentation: The Natural History of Becker Muscular Dystrophy
• Sam Collins, M.D., Ph.D., Vice President of Clinical Development, Edgewise Therapeutics
  • Presentation: 12-Month Data from ARCH, an Open Label Study in Becker Muscular Dystrophy
• Barry J. Byrne, M.D., Ph.D., Director, Powell Gene Therapy Center, University of Florida
  • Presentation: Putting the Data in Context

Only registered conference attendees can register for the symposium.

Scientific Posters

Title: Characterization of short- and long-term proteomic response to the fast skeletal myosin inhibitor, EDG-5506, in Becker muscular dystrophy (P.254)

Date: Friday, October 6, 2023, 2:00 – 3:00 pm ET

Title: Effects of EDG-5506, a fast myosin modulator, on function and biomarkers of muscle damage in adults with Becker muscular dystrophy (P.255)

Date: Friday, October 6, 2023, 2:00 – 3:00 pm ET

Title: Development of a conceptual model of the patient experience of Becker Muscular Dystrophy – a literature review and qualitative interview study (P.256)

Date: Friday, October 6, 2023, 2:00 – 3:00 pm ET

The full WMS Congress program is available here.

The Edgewise symposium presentation and posters will be available on the Edgewise website when they are presented.

About EDG-5506 for Becker and Duchenne Muscular Dystrophies

EDG-5506 is an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies including Duchenne and Becker. EDG-5506 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, EDG-5506 has the potential to benefit a broad range of patients suffering from debilitating genetic neuromuscular disorders. It is anticipated to be used as a single agent therapy, but it may also provide an additional benefit in combination with available therapies and therapies currently in development. In August 2021, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to EDG-5506 for the treatment of individuals with Becker.

The Company has completed a Phase 1 clinical trial of EDG-5506 designed to evaluate safety, tolerability, PK and pharmacodynamics of EDG-5506 in adult healthy volunteers (Phase 1a) and in adults with Becker (Phase 1b) (NCT04585464). In ARCH, an open-label, single-center trial (NCT05160415) assessing long-term safety and PK, decreases in biomarkers of muscle damage and trends toward improvement in NSAA have been observed following 12 months of treatment with EDG-5506. The Phase 2 trial of EDG-5506 in Becker (CANYON) has been expanded to include an additional 120 adult participants in a pivotal cohort called GRAND CANYON. CANYON is fully enrolled; GRAND CANYON is currently enrolling. LYNX, an ongoing Phase 2 trial (NCT05540860), is assessing safety, PK and biomarkers of muscle damage in participants with Duchenne. The Company is also continuing to recruit the DUNE Phase 2 exercise challenge study, to evaluate the effect of EDG-5506 on biomarkers of muscle damage following exercise in adults with LGMD2I, Becker or McArdle disease at a single site in Denmark.

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 first-in-class therapeutics. EDG-5506 is an orally administered skeletal myosin inhibitor in advanced clinical trials in patients with Becker, Duchenne, and Limb-Girdle muscular dystrophies as well as McArdle Disease. EDG-7500, currently in a Phase 1 trial, is a novel cardiac sarcomere modulator for the treatment of HCM and other disorders of cardiac diastolic dysfunction. 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 (formerly Twitter), Facebook, Instagram and Threads.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230927386586/en/