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

BOULDER, CO, USA I September 14, 2023 I Edgewise 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.

“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.”

Kevin 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.”

About EDG-7500 Phase 1 Clinical Trial

The 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.

About Hypertrophic Cardiomyopathy

HCM is the most common form of genetic heart disease with an estimated prevalence of as many as 700,000 people in the United States. The molecular underpinnings of HCM lead to abnormal cardiac sarcomeric protein function that eventually results in excessive contraction of the heart muscle, referred to as hypercontractility. Over time, hypercontractility increases the thickness (hypertrophy) of the heart’s left ventricular (LV) walls – the heart’s primary pumping chamber. Progressive hypertrophy eventually leads to a thick and stiff LV thereby reducing its ability to fill with blood during relaxation (diastole) and pump blood during contraction (systole). A decreased volume of blood entering and leaving the LV causes shortness of breath, rapid heartbeat, chest pain, unexplained fatigue, dizziness, and syncope (loss of consciousness), which together cause HCM patients to become limited in their ability to perform activities of daily living. HCM can be diagnosed at any age; disease progression increases the risk of heart failure, stroke and atrial fibrillation. Despite advancements in the development of therapies to treat HCM, there is currently a significant unmet need for additional therapies to safely and more effectively treat the disease.

About EDG-7500 for HCM

EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that is advancing in a Phase 1 trial. The compound is designed to slow early contraction velocity and improve impaired cardiac relaxation. This novel mechanism is anticipated to have a broad therapeutic index that may facilitate fixed patient dosing and minimize monitoring during therapy. Preclinical data of EDG-7500 support beneficial activity in animal models of both obstructive HCM and cardiac diastolic dysfunction with minimal changes in left ventricular systolic performance. The Company plans to present preclinical data of EDG-7500 at a major cardiovascular meeting later this year.

About Edgewise Therapeutics

Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The company’s deep expertise in muscle physiology is driving a new generation of first-in-class therapeutics. EDG-5506 is an orally administered skeletal myosin inhibitor in advanced clinical trials in patients with Becker, Duchenne, and Limb-Girdle muscular dystrophies as well as McArdle Disease. EDG-7500, currently in a Phase 1 trial, is a novel cardiac sarcomere modulator for the treatment of HCM and other disorders of cardiac diastolic dysfunction. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, X (formerly Twitter), Facebook, Instagram and Threads.

SOURCE: Edgewise Therapeutics