Edgewise Therapeutics, Inc. (EWTX) reported encouraging top-line results from its 12-week Phase 2 Part D CIRRUS-HCM trial evaluating EDG-7500 in patients with obstructive and nonobstructive hypertrophic cardiomyopathy, showing meaningful improvements in heart function without reductions in systolic performance.
Hypertrophic cardiomyopathy (HCM) is a chronic, progressive heart disease in which the heart muscle becomes abnormally thick, impairing relaxation and blood flow. Patients often experience shortness of breath, chest pain, fatigue, and reduced exercise capacity. Current treatment options can be limited, especially for those who do not respond well to standard therapies.
Primary Findings: No Impact on Systolic Function, Broad Clinical ImprovementsIn the study, EDG-7500 demonstrated no relationship between observed between drug exposure and left ventricular ejection fraction (LVEF), with no LVEF reductions below 50% observed across more than 700 echocardiograms performed in healthy adults and HCM patients.
EDG-7500 is a novel, oral, selective cardiac sarcomere modulator designed to slow early contraction velocity and improve impaired cardiac relaxation without compromising systolic function.
Across both obstructive (oHCM) and nonobstructive (nHCM) patient groups, the therapy produced consistent and clinically meaningful improvements in echocardiogram parameters, biomarkers, symptoms, and functional status.
About the CIRRUS-HCM Trial
CIRRUS-HCM is a multi-part (A-D), open-label study evaluating EDG-7500 in HCM patients. Part D, the focus of this announcement, enrolled 53 patients (20 oHCM, 33 nHCM) who received doses ranging from 25 mg to 150 mg over 12 weeks.
Dosing strategies differed by subtype:
-oHCM: guided by left ventricular outflow tract gradient (LVOT-G)
-nHCM: guided by NT-proBNP, a key heart-failure biomarker
Results in Obstructive HCM
Patients with oHCM showed broad improvements across multiple clinical measures:-90% demonstrated improvement in hemodynamic measures, including reductions in LVOT-G at rest and post-Valsalva.
-74% achieved NT-proBNP normalization (<150 pg/mL) or a 50% reduction from baseline.
-24 -point mean increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS)
-70% improved by at least one NYHA functional class level.
- ~20% increase in early diastolic mitral annular velocity (e' lateral), indicating improved diastolic function
-In a high-frame-rate substudy, E/e' improved by 5.3 points, suggesting enhanced diastolic relaxation.
Safety Profile
EDG-7500 continued to be generally well tolerated, with no meaningful reductions in LVEF observed across the dataset, supporting its differentiated mechanism for both oHCM and nHCM patients.
Next Steps
Part D of the CIRRUS-HCM trial is designed to inform a Phase 3 program, and Edgewise plans to advance EDG-7500 into late-stage development based on these results, with program initiation targeted for the fourth quarter of 2026.
EWTX has traded between $12.15 and $40.76 over the past year. The stock closed Monday's trading at $35.21, up 1.09%. In pre-market trading the stock is at $26.00, down 26.16%.
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