Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

• Status: Enrolling by invitation
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edgewise Therapeutics, Inc.
• Collaborator: Medpace, Inc.

Criteria

Inclusion Criteria:

1. Participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows:

• EDG-5506-002 ARCH: Complete the final study Visit 27 [Month 24]; or, completion of the ET visit prior to Visit 27 [Month 24]

• EDG-5506-201 CANYON and GRAND CANYON: Complete the final study visit (Cohorts 1, 2, 4, and 5: Visit 12 [Month 12]; Cohort 6: Visit 11 [Month 18])

• EDG-5506-202 DUNE: Complete at least 36 weeks of open-label treatment

Exclusion Criteria:

1. Any clinically significant changes during or following participation in EDG-5506-002, EDG-5506-201, or EDG-5506-202 that would affect the potential safety of the participant to receive sevasemten.

2. Receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.

3. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months.