Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a biopharmaceutical company specializing in muscle diseases, announced the commencement of its Phase 1 trial for EDG-7500. This oral, selective, cardiac sarcomere modulator targets diastolic dysfunction and diseases like hypertrophic cardiomyopathy (HCM). The randomized, double-blind, placebo-controlled trial will evaluate EDG-7500’s safety and pharmacokinetics in healthy adults. A Phase 1b study targeting individuals with obstructive hypertrophic cardiomyopathy is planned for the first half of 2024.

CEO Kevin Koch on Company’s Dedication to Muscle Diseases

Kevin Koch, President and CEO of Edgewise Therapeutics, stated, “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.”

Details of the Phase 1 Trial for EDG-7500

The Phase 1 trial will focus on the safety, tolerability, pharmacokinetics, and pharmacodynamics of EDG-7500 in healthy adults. Participants will receive either a single or multiple oral doses of EDG-7500 or a placebo. The trial aims to shed light on the drug’s effects and its potential for treating cardiac diseases like hypertrophic cardiomyopathy and diastolic dysfunction.

What EDG-7500 Means for the Future of Cardiac Treatments

EDG-7500 is a first-in-class cardiac sarcomere modulator that could revolutionize treatments for cardiac diseases. Its unique design targets early contraction velocity and impaired cardiac relaxation. Preclinical data suggest a broad therapeutic index for EDG-7500, which might lead to fixed patient dosing with minimal monitoring. The company plans to present these preclinical data at a significant cardiovascular meeting later this year.

  Diastolic Dysfunction, EDG-7500, Edgewise Therapeutics, hypertrophic cardiomyopathy, Kevin Koch, USA