Edgewise Therapeutics Announces Upcoming Presentation at the American College of Cardiology's 72nd Annual Scientific Session Together with World Congress of Cardiology

Rhea-AI Summary

Edgewise Therapeutics (NASDAQ: EWTX) announced the presentation of EDG-7500, a first-in-class oral therapy for hypertrophic cardiomyopathy (HCM), at the American College of Cardiology's 72nd Annual Scientific Session on March 5, 2023. This investigational drug aims to normalize excess cardiac contraction and improve impaired relaxation, addressing both obstructive and non-obstructive HCM. Key findings include significant improvements in cardiovascular pathophysiologies and potent gradient reductions. The company plans to initiate a Phase 1 trial for EDG-7500 in late 2023, supporting further clinical development based on promising preclinical data.

– Presentation highlights EDG-7500, an investigational first-in-class oral, selective, sarcomere modulator for hypertrophic cardiomyopathy (HCM) on March 5, 2023 –

BOULDER, Colo.--(BUSINESS WIRE)-- Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that the company will present on EDG-7500, an investigational therapy designed to normalize excess cardiac contraction (systolic) and deficient relaxation (diastolic), the underlying pathology of both obstructive and non-obstructive HCM, at the American College of Cardiology's 72^nd Annual Scientific Session Together with World Congress of Cardiology (ACC.23/WCC). The conference will take place at the New Orleans Ernest N. Morial Convention Center from March 4-6, 2023.

“EDG-7500 is a novel investigational therapy for the treatment of HCM with a differentiated mechanism of action,” said Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics. “The EDG-7500 data to-date has demonstrated improvements in meaningful cardiovascular disease pathophysiologies across multiple translatable preclinical disease models of HCM. Importantly, EDG-7500 has shown potent gradient reduction, normalization of hyperdynamic contractility, and significant improvements in ventricular filling in our preclinical studies. We believe that this work establishes a highly compelling data package to support clinical trials.”

Details of the Edgewise presentation at ACC.23/WCC:

Session: The Latest Hype In Hypertrophic Cardiomyopathy

Poster Presentation: 1066-13 - EDG-7500, A Novel Targeted Sarcomere Regulator Preserves Intrinsic Myosin-Motor Function, Blunts Hypercontractility and Eliminates LVOT Obstruction in Cats with Hypertrophic Cardiomyopathy: In Vitro and In Vivo Evidence

Presenter: Marc Evanchik., Vice President Discovery and Translational Pharmacology, Edgewise Therapeutics

Date: Sunday, March 5, 2023, 3:45 pm-3:55 pm CT

The scientific poster will be available on the Edgewise website after it is presented.

About EDG-7500 for Hypertrophic Cardiomyopathy

EDG-7500 is an investigational first-in-class oral, selective, sarcomere modulator for HCM. The compound is designed to slow contraction velocity and improve impaired cardiac relaxation, hallmarks of HCM. This novel mechanism is anticipated to have a broader therapeutic index relative to direct cardiac myosin inhibition. The Company is advancing the compound through IND-enabling studies with plans to initiate a Phase 1 trial in the second half of 2023. EDG-7500 is a result of Edgewise’s robust discovery platform that is yielding novel compounds targeting important unmet needs of patients suffering from inherited disorders of cardiac and skeletal muscle. Preclinical data of EDG-7500 support activity in both obstructive HCM and non-obstructive HCM with minimal changes in left ventricle ejection fraction (LVEF). Further, EDG-7500’s novel mechanism of action supports investigating fixed dose regimens. In January 2023, the Company introduced the program during an investor event, sharing a scientific overview and clinical development plans for EDG-7500. A replay of the event and presentation slides can be found on the Edgewise website here.

About Edgewise Therapeutics

Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare neuromuscular and cardiac disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle-focused drug discovery platform. Edgewise’s platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue. The Company’s lead candidate, EDG-5506, an investigational orally administered small molecule designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, is advancing in multiple clinical trials in individuals with Duchenne, Becker and Limb Girdle 2i muscular dystrophies, and McArdle’s disease. The Company is also advancing EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy, into IND-enabling preclinical development. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, Twitter and Facebook.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise’s drug discovery platform, product candidates and programs, including EDG-7500; statements about the expected timing of Edgewise’s initiation of a Phase 1 clinical trial for EDG-7500; and statements by Edgewise’s president and chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company including the potential for Edgewise’s product candidates to cause serious adverse events; Edgewise’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for muscular dystrophy patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for EDG-7500; Edgewise’s ability to obtain IND clearance for EDG-7500; Edgewise’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Edgewise’s operations, including preclinical and clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Edgewise’s ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise’s manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise’s product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise’s reliance on third parties; Edgewise’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Edgewise files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230228005215/en/

Investors & Media

Michael Carruthers

Chief Financial Officer

ir@edgewisetx.com

Source: Edgewise Therapeutics

FAQ

What is EDG-7500 and its significance for hypertrophic cardiomyopathy?

EDG-7500 is an investigational first-in-class oral therapy designed to normalize cardiac contraction and improve relaxation in hypertrophic cardiomyopathy (HCM), showing promise in preclinical studies.

When and where will Edgewise Therapeutics present their findings on EDG-7500?

Edgewise Therapeutics will present findings on EDG-7500 at the American College of Cardiology's 72nd Annual Scientific Session from March 4-6, 2023, with a specific poster presentation on March 5, 2023.

What improvements have been observed with EDG-7500 in preclinical studies?

Preclinical studies of EDG-7500 have shown significant reductions in hypercontractility, improvements in ventricular filling, and normalization of cardiac function.

What are the next steps for the development of EDG-7500?

Edgewise Therapeutics plans to initiate a Phase 1 clinical trial for EDG-7500 in the second half of 2023, following IND-enabling studies.

Who is presenting the research on EDG-7500 at ACC.23?

The research on EDG-7500 will be presented by Marc Evanchik, Vice President of Discovery and Translational Pharmacology at Edgewise Therapeutics.