– Phase 2 trial evaluating EDG-15400 in adults with symptomatic HFpEF with a LVEF of at least 50% –
– EQUINOX-HFpEF trial design and EDG-15400 Phase 1 first-in-human data to be presented at HFSA 2026 –
BOULDER, Colo., Oct. 8, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading clinical-stage biopharmaceutical company focused on cardiometabolic diseases, today announced the dosing of the first patient in EQUINOX-HFpEF, a Phase 2 clinical trial evaluating EDG-15400 in adults with symptomatic heart failure with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) of at least 50%.
EDG-15400 is an investigational, oral, selective cardiac sarcomere modulator that has demonstrated improvements in diastolic function in preclinical models. A product of the Edgewise cardiovascular discovery platform, EDG-15400 is intended to address impaired cardiac relaxation, a defining feature of HFpEF that contributes to symptoms and disease burden.
"Dosing the first patient in the EQUINOX-HFpEF trial marks an important milestone in evaluating EDG-15400's potential to improve the impaired cardiac relaxation that characterizes HFpEF," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise Therapeutics. "This study seeks to extend our cardiac sarcomere platform into an underserved patient population and will help determine whether this differentiated mechanism can benefit patients with symptomatic HFpEF."
"HFpEF remains one of the most challenging forms of heart failure to treat, in part because current therapies do not directly address impaired cardiac relaxation," said James L. Januzzi, M.D., Chair of the EQUINOX-HFpEF Executive Committee and the Hutter Family Professor of Medicine at Harvard Medical School. "Based on preclinical observations, EDG-15400 may represent a more direct approach to HFpEF."
Phase 2 EQUINOX-HFpEF Trial of EDG-15400
EQUINOX-HFpEF is a Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating EDG-15400 in adults with symptomatic HFpEF. The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-15400.
The trial is expected to enroll approximately 90 adults aged 30 to 84 years with HFpEF. Participants will receive once-daily oral doses of 25 mg or 50 mg of EDG-15400, or placebo, for up to 12 weeks. The study will enroll participants with HFpEF who have a LVEF of at least 50% and New York Heart Association functional class II or III symptoms.
HFSA 2026 Presentations
The Company also announced upcoming presentations at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, taking place October 9-12 in Phoenix, Arizona:
Title: EQUINOX-HFpEF: A Phase 2 Study of EDG-15400, a Selective Cardiac Sarcomere Modulator, in Adults with Heart Failure with Preserved Ejection Fraction (ePoster)
Date: October 10, 2026, 1:15 – 1:45 pm MT
Title: EDG-15400, a Cardiac Sarcomere Modulator, Demonstrated Favorable Pharmacokinetics, Pharmacodynamics and Tolerability in Healthy Adult Participants (Rapid Fire Oral Presentation)
Date: October 12, 2026, 12:15 – 1:15 pm MT
The Edgewise presentation and poster will be available on the Edgewise website following the presentations.
About Heart Failure with Preserved Ejection Fraction
HFpEF is a form of heart failure in which the heart's main pumping chamber retains a preserved ejection fraction but does not relax and fill normally. Diastolic dysfunction is central to HFpEF and can contribute to symptoms including shortness of breath, swelling, fatigue and weakness, substantially affecting patients' daily activities and quality of life. Despite recent treatment advances, additional therapies are needed to more directly address the underlying cardiac dysfunction associated with HFpEF.
About Edgewise Therapeutics
Edgewise Therapeutics is a leading biopharmaceutical company focused on developing innovative therapies for serious cardiovascular and cardiometabolic diseases. Leveraging its expertise in integrated muscle physiology and small molecule drug development, Edgewise is advancing a cardiovascular pipeline targeting significant unmet needs, including hypertrophic cardiomyopathy and heart failure. To learn more, go to edgewisetx.com or follow Edgewise on LinkedIn, X, Facebook and Instagram.
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 benefits and potential of, and expectations regarding, EDG-15400; statements regarding the market opportunity for EDG-15400 and the size and needs of the HFpEF patient population; statements regarding Edgewise's expectations relating to its clinical trials, including the Phase 2 EQUINOX-HFpEF trial of EDG-15400; statements regarding the presentation of the EQUINOX-HFpEF trial design and EDG-15400 Phase 1 first-in-human data at the HFSA Annual Scientific Meeting 2026; and statements by Edgewise's President and Chief Executive Officer and the Chair of the EQUINOX-HFpEF Executive Committee. 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: the potential for the results of the ongoing or any future clinical trial of EDG-15400, including the Phase 2 EQUINOX-HFpEF trial, to differ from the results of preclinical studies and the Phase 1 trial of EDG-15400; the risk that preclinical findings of EDG-15400 may not translate into clinical benefit in humans; the risk of delays in, or the failure to initiate, enroll, complete or report data from, the EQUINOX-HFpEF trial; risks associated with Edgewise's limited operating history, its product candidates being early in development and not having products approved for commercial sale; risks associated with Edgewise not having generated any revenue to date; Edgewise's ability to achieve objectives relating to the discovery, development and commercialization of its product candidates, if approved; Edgewise's need for substantial additional capital to finance its operations; Edgewise's dependence on the success of its product candidates, including EDG-15400; Edgewise's ability to develop and commercialize EDG-15400; risks related to Edgewise's clinical trials of its product candidates not demonstrating safety and efficacy; risks related to Edgewise's product candidates causing serious adverse events, toxicities or other undesirable side effects; the outcome of preclinical testing and clinical trials not being predictive of the success of later clinical trials and the risks related to the results of Edgewise's clinical trials not satisfying the requirements of regulatory authorities; delays or difficulties in the enrollment and/or maintenance of patients in clinical trials; risks related to failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim, topline and preliminary data from Edgewise's clinical trials changing as more patient data becomes available; risks related to failure to develop a proprietary drug discovery platform; risks related to production of drugs by Edgewise's third-party manufacturers; risks related to changes in methods of product candidate manufacturing or formulation; risks related to not achieving adequate market acceptance; risks related to the regulatory approval processes of domestic and foreign authorities being lengthy, time consuming and inherently unpredictable; risks relating to disruptions at the FDA, the SEC and other government agencies; risks relating to Edgewise's ability to attract and retain highly skilled executive officers and employees; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; Edgewise's reliance on third parties; risks related to future acquisitions or strategic partnerships; risks related to Edgewise's future operations following the sale of sevasemten; risks relating to Edgewise not receiving milestone payments related to the sale of sevasemten; risks related to 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.
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