Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Summary
A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 175 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker.
Timeline
- Start
- 2022-11-10
- Primary completion
- 2026-09-07
- Completion
- 2026-09-07
Outcome
Met primary endpoint
release “The trial met its primary endpoint of change from baseline in CK. CANYON is the largest interventional trial to date in Becker” edgewisetx.com ↗
release “The results demonstrated a significant change from baseline in CK in the sevasemten-treated group (difference vs. placebo, 28% average decrease over months 6 through 12; p=0.02).” edgewisetx.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sevasemten | Small molecule | 5 mg | Oral |
| Subject | Sevasemten | Small molecule | 10 mg | Oral |
| Subject | Sevasemten | Small molecule | 12.5 mg | Oral |