Edgewise Achieves 98%-Powered Sevasemten Trial with 175 Patients, Revises HCM Screening
Edgewise boosted sevasemten enrollment in the GRAND CANYON trial to 175 patients, powering it at 98% to detect a 1.8-point improvement and targeting a Q4 readout. The company revised EDG-7500 HCM protocols with core-lab echocardiograms, a 180-day AFib look-back and excluded high-risk valve patients before Part D data release.
1. Sevasemten GRAND CANYON Enrollment Boosted
Edgewise increased sevasemten enrollment to 175 participants, powering the Becker muscular dystrophy pivotal trial at roughly 98% to detect a 1.8-point North Star improvement. The company remains on track for a Q4 readout and is targeting potential approval by end-2027.
2. HCM Protocol Revisions
Edgewise revised EDG-7500 hypertrophic cardiomyopathy screening by shifting echocardiogram confirmation to a central core lab, extending the atrial fibrillation look-back window to 180 days, excluding moderate-to-severe mitral stenosis patients and implementing four-week continuous cardiac monitoring, reporting no AFib burden or LVEF relationship.
3. Pipeline Milestones and Planning
The company expects EDG-15400 SAD/MAD healthy-volunteer data in Q2, plans an HFpEF Phase 2 trial in Q3–Q4 and will decide on a Duchenne program following the GRAND CANYON readout. EDG-7500 Part D results are scheduled for release before initiating a Phase 3 program in Q4.
4. Regulatory and Monitoring Strategy
Edgewise’s data indicate no correlation between EDG-7500 plasma concentration and LVEF, which it believes may preclude intensive REMS requirements. The proposed monitoring framework includes baseline and end-of-study echocardiograms to support broader adoption beyond centers of excellence.