Edgewise doses 1st patient in CIRRUS-HCM of EDG-7500 trial for HCM

Edgewise Therapeutics announced the dosing of the first patient in the Phase 2 CIRRUS-HCM trial of EDG-7500. EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunction. The Phase 2 trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in patients with obstructive HCM. Part A of the trial will evaluate single doses and Part B will evaluate multiple oral doses of EDG-7500 over 28 days. “Based on the strength of clinical and preclinical data to-date, we are advancing EDG-7500 into the Phase 2 CIRRUS-HCM trial in patients with obstructive HCM,” said Marc Semigran, M.D., Chief Development Officer, Edgewise Therapeutics. “We are encouraged by the effects of EDG-7500 observed in a translatable preclinical disease model of obstructive HCM. EDG-7500 demonstrated potent left ventricular outflow tract gradient relief while maintaining overall normal LV contractility. Importantly, in preclinical models of non-obstructive HCM, both acute and chronic administration of EDG-7500 has also been observed to be associated with significant improvements in ventricular filling and diastolic function.” Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics added, “Advancing EDG-7500 into patients with obstructive HCM is an important milestone for Edgewise. EDG-7500 is representative of the robust discovery and development capabilities at Edgewise and our commitment to patients with serious muscle diseases.” The Company expects to report data from the single dose arm of this trial and a Phase 1 trial of EDG-7500 in healthy volunteers in the third quarter of 2024. Furthermore, the Company expects to initiate a 28-day trial in patients with obstructive and non-obstructive HCM in the second half of 2024. The Company also expects to begin an open-label extension trial of EDG-7500 in the fourth quarter of 2024.