Edgewise plans Phase 3 EDG-7500 trial with dosing independent of echocardiogram monitoring
EWTX•Edgewise Therapeutics plans to start its Phase 3 STRATUS-HCM trial of EDG-7500 in the fourth quarter of 2026, with dose escalation based on tolerability rather than echocardiograms. The placebo-controlled trial will enroll about 600 adults with symptomatic hypertrophic cardiomyopathy and assess functional capacity after 24 weeks of treatment.
1. Trial plans
Edgewise Therapeutics plans to start the Phase 3 STRATUS-HCM trial of EDG-7500 in the fourth quarter of 2026 following favorable FDA feedback. The submitted protocol bases dose escalation on tolerability without using echocardiograms to guide dosing.
2. Study design
The placebo-controlled trial will enroll approximately 600 adults with symptomatic hypertrophic cardiomyopathy, evaluating obstructive and nonobstructive populations independently. After 24 weeks of treatment, patients will enter a long-term extension; the primary endpoint assesses changes in functional capacity. Phase 2 data were presented to the FDA during the end-of-phase meeting.
