Edgewise Therapeutics (NASDAQ:EWTX) said it has completed Parts B and C of the CIRRUS-HCM study and reported favorable interim safety data from Part D for EDG-7500, its selective oral cardiac sarcomere modulator being developed for obstructive and nonobstructive hypertrophic cardiomyopathy.
Parts B and C of the mid-stage trial enrolled 43 participants across 25-milligram, 50-milligram and 100-milligram dose cohorts.
The company said patients showed improvements across multiple disease and quality-of-life measures, including NT-proBNP, Kansas City Cardiomyopathy Questionnaire scores, New York Heart Association functional class and left ventricular outflow tract gradient in obstructive HCM.
Part D of CIRRUS-HCM has enrolled more than 40 participants so far, with about 70% titrated to doses of at least 100 milligrams.
As of a Dec. 23, 2025 data cutoff, 20 participants — eight with obstructive HCM and 12 with nonobstructive disease — had completed 12 weeks of treatment.
Edgewise said no clinically meaningful declines in left ventricular ejection fraction were observed, and no participant experienced an ejection fraction below 50%.
More than 300 ambulatory cardiac monitors captured over 2,600 patient-days of rhythm data, during which no atrial fibrillation or atrial flutter was detected.
One atrial fibrillation event was reported outside of monitoring and was deemed not related to EDG-7500.
The company expects to report full results from Part D in the second quarter of 2026 and said it is targeting the start of a Phase 3 program in the fourth quarter of 2026.