Edgewise Therapeutics, Inc. announced the dosing of the first patient in the Phase 2 CIRRUS-HCMtrial 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 (PK) 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. 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.