EDG-7500 Advances Phase 2 HCM Trial With Dual Benefits in Sarcomere Function and Safety Profile

Edgewise Therapeutics (EWTX) has revealed significant progress in its clinical development program for hypertrophic cardiomyopathy treatment. The company successfully concluded Parts B and C of the Phase 2 CIRRUS-HCM trial evaluating EDG-7500, while interim findings from the ongoing Part D study demonstrate a reassuring safety signature that sets this cardiac sarcomere modulator apart from competing approaches.

Understanding the Unmet Need in HCM

Hypertrophic cardiomyopathy remains the leading inherited cardiac disorder, impacting approximately one in every 500 individuals. Beyond the genetic component, HCM patients face substantial quality-of-life challenges including heightened risk of sudden cardiac death, arrhythmias, and progressive heart failure. Existing treatment options often introduce systolic dysfunction complications, creating a clinical gap for safer therapeutic alternatives that preserve normal cardiac function.

How EDG-7500’s Sarcomere Function Mechanism Works

EDG-7500 operates as a selective oral cardiac sarcomere modulator, targeting the fundamental contractile machinery of the heart. By modulating sarcomere function to reduce early contraction velocity while promoting improved diastolic relaxation, the drug addresses HCM pathophysiology without compromising systolic performance—a critical distinction from earlier myosin inhibitor approaches.

Trial Results Across HCM Subtypes

Part A established proof-of-concept in April 2025, with a four-week dosing study showing rapid clinical improvements including LVOT gradient reduction and enhanced patient-reported outcomes. Notably, no meaningful left ventricular ejection fraction (LVEF) reduction occurred.

The obstructive HCM cohort enrolled in Part B revealed dose-dependent enhancements across multiple clinical markers: NT-proBNP reduction, improved Kansas City Cardiomyopathy Questionnaire scores, better New York Heart Association functional class, and reduced left ventricular outflow tract gradients.

Part C extended findings to non-obstructive HCM patients, demonstrating NT-proBNP improvements and favorable diastolic function trends, confirming that sarcomere function optimization benefits both HCM phenotypes.

Safety Data From Ongoing Part D Study

Interim Part D data reinforces EDG-7500’s tolerability advantage. The compound showed no clinically significant LVEF reductions and zero atrial fibrillation cases detected under continuous cardiac monitoring—outcomes that differentiate its safety profile substantially from alternative sarcomere-targeting agents.

Development Timeline and Stock Performance

Edgewise expects to release the complete 12-week Part D dataset in Q2 2026, with Phase 3 initiation targeted for year-end 2025. Market response has been positive, with EWTX trading at $22.75 in pre-market activity, representing a 4.62% increase. Over the past year, the stock has ranged between $10.60 and $30.48.

The preservation of systolic function through EDG-7500’s mechanism could substantially reduce clinical monitoring requirements and potentially expand the eligible patient population upon regulatory approval.