Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the Company will present the results of nonclinical studies of EDG-7500 at the American Heart Association’s (AHA) Scientific Sessions 2023 being held in Philadelphia from November 11 - 13. 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 hypertrophic cardiomyopathy (HCM) and other diseases of diastolic dysfunction.

Details of the Rapid Fire Oral Presentation:

Title: EDG-7500, a Novel Cardiac Sarcomere Regulator That Preserves Intrinsic Myosin-Motor Function, Improves Cardiac Function and Reserve in a Minipig Model of Hypertrophic Cardiomyopathy

Session: The Pharmacologic Management of Heart Failure: Beyond Guidelines and Paradigms

Date and Time: Monday, November 13, 2023, 2:20 – 2:25 pm ET

Details of the Scientific Poster Presentation:

Title: Cardiac Effects of EDG-7500, a Novel Cardiac Sarcomere Regulator: In Vitro and In Vivo Evidence for Slowing Isovolumic Contraction and Improved Ventricular Compliance (Board #2163)

Session: Bench to Bedside: Novel Therapeutic Approaches in Heart Failure

Date and Time: Saturday, November 11, 2023, 11:30 am – 12:45 pm ET

The AHA Scientific Sessions’ program is available here. The Edgewise presentation and poster will be available on the Edgewise website when they are presented.

About EDG-7500 for Hypertrophic Cardiomyopathy

EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator produced by the Company’s robust discovery platform. The compound is specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunction. The Company is enrolling a Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose study of EDG-7500 evaluating safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adults. To learn more about this study (NCT06011317), go to clinicaltrials.gov. 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.

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.

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 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.

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