Edgewise Therapeutics CIRRUS-HCM Phase 2 Study's Part D Demonstrates EDG-7500 Was Well Tolerated; No Clinically Meaningful Reductions In LVEF Or LVEF <50%

Edgewise Therapeutics, Inc., (Nasdaq: EWTX), today announced positive updates from the ongoing CIRRUS-HCM, Phase 2 clinical trial of EDG-7500, a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with hypertrophic cardiomyopathy (HCM) without impacting systolic function, two central clinical goals in the current management of HCM.

CIRRUS-HCM is a multi-part, open label trial of EDG-7500 in participants with obstructive and nonobstructive HCM. Earlier this year, the Company reported positive top-line results from the Part B (oHCM, n=17) and Part C (nHCM, n=12) 50 mg and 100 mg fixed dose cohorts, in which EDG-7500 administration led to improvements in key HCM disease markers, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), Kansas City Cardiomyopathy Questionnaire (KCCQ), New York Heart Association (NYHA) class and left ventricular outflow tract gradient (LVOT-G) (in oHCM participants). In both Parts B and C, EDG-7500 administration led to KCCQ score improvements that appeared favorable relative to those reported in other cardiovascular trials, including those with cardiac myosin inhibitors (CMIs). EDG-7500 administration was also associated with measurable improvements in key diastolic parameters, including robust reductions in NT-proBNP, reduced left ventricular filling pressures, and improved relaxation metrics.