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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
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.
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
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 beneficialactivity 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
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 EDG-7500; statements regarding Edgewise's expectations relating to its preclinical studies and clinical trials, including the commencement of trials (including the Phase 1b study of EDG-7500 in individuals with obstructive HCM) and statements by Edgewise's president and chief executive officer and chief development 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; the timing, progress and results of preclinical studies and clinical trials for EDG-7500; Edgewise's ability to raise any additional funding it will need to continue to pursue its business and product development plans; 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
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