Edgewise Therapeutics Announces Positive Two-Year Topline Results from the ARCH Open Label Trial of Sevasemten (EDG-5506) in Adults with Becker Muscular Dystrophy (Becker) - Seite 2

The positive results from the two-year ARCH trial further support the hypothesis that a reduction in contraction-induced muscle damage in muscular dystrophies has the potential to preserve function and halt disease progression in Becker.

Upcoming ARCH 24-Month Data Presentations with Investor, Medical and Patient Communities:

Virtual Investor Event

Members of the Edgewise management team will hold a live webcast on Tuesday, April 16, at 8:30 a.m. ET to discuss the ARCH two-year data, and will be joined by Dr. Byrne, who will share his perspective of sevasemten and Becker. An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit the Edgewise events page.

American Academy of Neurology 2024 Annual Meeting Podium Presentation

Session: Inherited Myopathies and Neuropathies: New Therapeutic Approaches and Observations

Title: Effects of EDG-5506, a Fast Myosin Modulator, on Function and Biomarkers of Muscle Damage in Adults with Becker Muscular Dystrophy

Presenter: Joanne Donovan, M.D., Ph.D., Chief Medical Officer, Edgewise Therapeutics

Date: Tuesday, April 16, 2024, 1:12 p.m. ET

The presentation will be available on the Edgewise website when it’s presented.

Patient Community Webinar

Members of Edgewise management will hold a community webinar on Monday, May 13 at 1 p.m. ET to discuss these data and the GRAND CANYON pivotal study. Further event details will be shared when they are available.

About the ARCH Open-Label Trial

ARCH, an open-label, single-center trial, assessed sevasemten in 12 adult males with Becker. The trial evaluated sevasemten administered daily over two years. Safety, tolerability, PK, changes in biomarkers of muscle damage such as CK and fast skeletal muscle troponin I, measures of function and patient-reported outcomes were evaluated. Go to clinicaltrials.gov to learn more about this trial (NCT05160415).

About GRAND CANYON, a Global Pivotal Study in Becker

The Company is advancing GRAND CANYON, a global pivotal study of EDG-5506 in individuals with Becker. GRAND CANYON is an expansion of the CANYON placebo-controlled trial. CANYON, which was over-enrolled, includes cohorts of 40 adults and 29 adolescents and a treatment period of 12 months. The Company expects to report CANYON data in the fourth quarter of 2024. GRAND CANYON is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EDG-5506 in adults with Becker. Data from GRAND CANYON, if positive, could support a marketing application. The primary endpoint of GRAND CANYON is NSAA. In addition, other functional assessments, biomarkers of muscle damage and safety will be assessed. GRAND CANYON is anticipated to recruit approximately 120 individuals with Becker, aged between 18 and 50 years old, at up to 50 sites in 10 countries. The treatment period for participants will be 18 months. To learn more, go to clinicaltrials.gov (NCT05291091) or the GRAND CANYON microsite: https://www.beckergcstudy.com.