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Edgewise Therapeutics Begins Dosing First-in-Human Phase 1 Trial of EDG-7500, its Lead Clinical Candidate for Hypertrophic Cardiomyopathy (HCM) and Other Serious Diseases of Cardiac Diastolic Dysfunction
– EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that has the potential to benefit a broad spectrum of HCM and other
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that has the potential to benefit a broad spectrum of HCM and other cardiomyopathy patients –\n\n\n BOULDER, Colo.--(BUSINESS WIRE)--\nEdgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class 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 1 trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in healthy adults. The Company is also planning to begin a Phase 1b study of EDG-7500 in individuals with obstructive HCM in the first half of 2024.\n\n\n“Initiation of our Phase 1 study of EDG-7500, our first cardiovascular therapeutic candidate, is an important milestone for our company,” said Marc Semigran, M.D., Chief Development Officer, Edgewise Therapeutics. “I have spent over 30 years working to help patients with serious heart disease and am excited about the potential of EDG-7500 to help individuals affected by HCM, where significant unmet needs remain.”\n\n\nKevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics added, “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. 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.”\n\n\nAbout EDG-7500 Phase 1 Clinical Trial\n\n\nThe Phase 1 trial is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in healthy adults. Participants enrolled in this study will receive a single oral dose or multiple oral doses of EDG-7500 or a placebo. To learn more about this study (NCT06011317), go to clinicaltrials.gov.\n\n\nAbout Hypertrophic Cardiomyopathy\n\n\nHCM i...