24/7 Market News- Edgewise Therapeutics Reports Positive Data from Phase 1 Trial in Healthy Subjects and Phase 2 CIRRUS-HCM Trial

September 19, 2024

DENVER, Colo., Sep 19, 2024 (247marketnews.com)- Edgewise Therapeutics (Nasdaq: EWTX) stated that EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF) in a Phase 1 in healthy subjects.

Edgewise Therapeutics further reported that its CIRRUS-HCM single-dose trial of EDG-7500 in obstructive HCM demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without meaningful changes in LVEF.

top-line data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 CIRRUS-HCM trial in patients with obstructive HCM. 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.

Marc Semigran, M.D., Chief Development Officer of Edgewise Therapeutics, commented, “Based on the strength of clinical and preclinical data to-date, we have initiated the 28-day part of CIRRUS-HCM in patients with obstructive and non-obstructive HCM.

“Importantly, we plan to continue the evaluation of tolerability, pharmacokinetics and effects on LVOT-G, LVEF, biomarkers and measures of feel and function in these patients.”

Kevin Koch, Ph.D., CEO and President of Edgewise Therapeutics added, “We believe our innovative approach, where we have observed gradient relief without reductions in LVEF, has the potential to be a valuable advancement in the treatment of obstructive HCM. We expect to report initial 28-day data in the first quarter of 2025.”

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