Edgewise Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, will present today at the 42nd Annual J.P. Morgan Healthcare Conference at 10:30 am PT (1:30 pm ET), and a live webcast will be available at www.edgewisetx.com. Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

“In 2023, we had tremendous progress in the clinic advancing our novel oral therapeutics that are designed to treat severe muscle conditions,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “We are well positioned to execute on our 2024 milestones including important EDG-5506 data in muscular dystrophies, first-in-human studies in our EDG-7500 cardiac program, as well as preclinical exploration of novel cardiometabolic targets.”

2023 Accomplishments

Musculoskeletal Program – EDG-5506

Becker muscular dystrophy (Becker)

• Announced positive 12-month open label ARCH trial data. ARCH is an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, function and pharmacokinetics (PK) of EDG-5506 in adults with Becker.
• Over-enrolled the Phase 2 CANYON placebo-controlled cohorts with 40 adults and 29 adolescents.
• Initiated GRAND CANYON, a global pivotal cohort in individuals with Becker. GRAND CANYON is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EDG-5506 in adults with Becker.
• Initiated Phase 2 open-label extension MESA trial that will assess the long-term effect of EDG-5506 on safety, biomarkers and functional measures. MESA will provide continued access to EDG-5506 treatment to study participants who were previously enrolled in Edgewise studies.
• Advanced Phase 2 DUNE exercise challenge study to evaluate the effect of EDG-5506 on biomarkers of muscle damage following controlled exercise in adults with Becker, Limb Girdle muscular dystrophy2I/R9 or McArdle disease.
• U.S. Food & Drug Administration (FDA) granted EDG-5506 Orphan Drug Designation for the treatment of Becker.

Duchenne muscular dystrophy (Duchenne)