Edgewise Therapeutics has begun dosing healthy adults in a Phase I study of EDG-7500 to treat hypertrophic cardiomyopathy (HCM) and other diseases of cardiac diastolic dysfunction.
The single and multiple ascending dose, placebo-controlled, double-blind, randomised study will assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of the cardiac sarcomere modulator EDG-7500.
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Nearly 126 participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.
Incidence of treatment-emergent adverse events up to 25 days of monitoring is the primary outcome measure of the study.
Secondary outcome measures include determining pharmacokinetics parameters, as measured by Tmax, Cmax, AUC, terminal half-life, and renal clearance.
Edgewise Therapeutics president and CEO Kevin Koch said: “We are pleased to add EDG-7500 to our growing clinical pipeline demonstrating our commitment to developing precision therapies for patients with severe genetic muscle diseases.
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By GlobalData“EDG-7500 is representative of the robust discovery and development capabilities at Edgewise, and our commitment to patients with serious skeletal and cardiac muscle diseases.
“As we mark this achievement, we look forward to initiating trials next year in HCM, and broadly in disorders of diastolic dysfunction.”
EDG-7500 can slow down early contraction velocity and improve impaired cardiac relaxation associated with HCM.
Minimal changes in left ventricular systolic performance was also demonstrated in animal models of both obstructive HCM and cardiac diastolic dysfunction.
The company is also planning to commence a Phase Ib trial of EDG-7500 in the first half of next year for obstructive HCM.
