Edgewise Completed Phase 2 CIRRUS-HCM Parts B And C, Reports Favorable Interim Safety From Part D

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Edgewise Therapeutics, Inc. (EWTX), today announced completion of Parts B and C of its Phase 2 CIRRUS-HCM trial evaluating EDG-7500 in hypertrophic cardiomyopathy, alongside favorable interim safety results from the ongoing Part D study.

Hypertrophic cardiomyopathy (HCM) is the most common genetic heart disease, affecting about one in 500 people, and is associated with reduced quality of life and increased risk of heart failure, arrhythmias, and sudden cardiac death. Current therapies often carry risks of systolic dysfunction, underscoring the need for safer alternatives.

EDG-7500, a novel oral cardiac sarcomere modulator, is designed to slow early contraction velocity and improve cardiac relaxation without impairing systolic function.

Part A:

In April 2025, Edgewise released positive top-line results from Part A of the CIRRUS-HCM trial, a four-week study that showed rapid and clinically meaningful reductions in LVOT gradients, improvements in patient-reported outcomes, and favorable biomarker changes, with no meaningful reductions in LVEF.

Part B:

Part B enrolled patients with obstructive HCM. EDG-7500 demonstrated dose-dependent improvements in NT-proBNP, Kansas City Cardiomyopathy Questionnaire scores, New York Heart Association class, and left ventricular outflow tract gradient.

Part C:

Part C focused on patients with non-obstructive HCM. EDG-7500 showed reductions in NT-proBNP and positive trends in diastolic function, reinforcing its potential across different HCM subtypes.

Part D:

Interim data from the ongoing Part D study showed EDG-7500 was generally well tolerated, with no clinically meaningful reductions in left ventricular ejection fraction and no atrial fibrillation events detected under continuous monitoring. These findings highlight EDG-7500's differentiated safety profile compared to cardiac myosin inhibitors.

Edgewise plans to deliver the full 12-week Part D readout in the second quarter of 2026 and initiate Phase 3 trials by year-end.

The company emphasized that preservation of systolic function could reduce monitoring burdens and expand patient access if approved.

EWTX has traded between $10.60 and $30.48 over the past year. The stock is currently trading in the pre-market at $22.75, up 4.62%.

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