Core Insights - Edgewise Therapeutics announced positive top-line data from the Phase 2 CIRRUS-HCM trial for EDG-7500, showing significant reductions in left ventricular outflow tract gradients in patients with obstructive hypertrophic cardiomyopathy (HCM) [1][2] - The treatment demonstrated improvements in cardiac function and biomarkers without adversely affecting left ventricular ejection fraction (LVEF) [1][4] Group 1: Trial Overview - CIRRUS-HCM is a multi-part, open-label trial assessing EDG-7500 in individuals with both obstructive and nonobstructive HCM [2][10] - Part B included 17 participants with obstructive HCM, while Part C included 12 participants with nonobstructive HCM, evaluating the safety and efficacy of daily doses of 50 or 100 mg over four weeks [3][10] Group 2: Efficacy Results - In obstructive HCM participants, EDG-7500 led to a 71% reduction in resting LVOT gradient and a 58% reduction in provokable gradient at the 100 mg dose, alongside a 62% mean reduction in NT-proBNP, a heart failure biomarker [4][6] - Participants also showed a substantial mean increase of 23 points in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) at the 100 mg dose [4][5] Group 3: Safety Profile - EDG-7500 was generally well-tolerated, with no participants experiencing LVEF values below 50% [1][6] - Common adverse events included dizziness and upper respiratory infections, with most being mild to moderate in severity [6] Group 4: Future Directions - The company plans to optimize dosing strategies in Part D of the trial, with initial data expected in the second half of 2025 and Phase 3 initiation planned for the first half of 2026 [8][10]
Edgewise Therapeutics Announces Positive Top-Line Results from Phase 2 CIRRUS-HCM Four-Week Trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM)