Edgewise Therapeutics advanced EDG-7500 toward phase III for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) after reporting improved phase II topline data. The company cited better tolerability and safety versus standard of care, alongside hemodynamic, biomarker, and patient-reported improvements. Edgewise highlighted the absence of meaningful left ventricular ejection fraction (LVEF) decline below 50%, an issue seen with marketed cardiac myosin inhibitors that carry boxed warnings. The company’s approach uses an oral, selective cardiac sarcomere modulator designed for partial inhibition. The next milestone is how EDG-7500 performs in a registrational design and whether the safety differentiation holds when endpoints broaden in phase III across obstructive/nonobstructive subgroups.
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