Edgewise Therapeutics has reported top-line results from Part D of the Phase 2 CIRRUS-HCM trial evaluating EDG-7500 in patients with obstructive hypertrophic cardiomyopathy (oHCM) and nonobstructive hypertrophic cardiomyopathy (nHCM). The findings support plans to advance the candidate into Phase 3 development, with program initiation targeted for the fourth quarter of 2026.
The results come as Bristol Myers Squibb’s Camzyos and Cytokinetics’ Myqorzo are approved by the U.S. Food and Drug Administration for the treatment of oHCM. Cytokinetics also reported a Phase 3 success in nHCM last month.
Part D of CIRRUS-HCM was a 12-week, open-label cohort designed to inform Phase 3 development. The study enrolled patients with oHCM and nHCM who received doses ranging from 25 mg to 150 mg. Dosing in oHCM was guided by left ventricular outflow tract gradient (LVOT-G), while dosing in nHCM was guided by N-terminal pro-B-type natriuretic peptide (NT-proBNP). A total of 53 patients completed the study, including 20 with oHCM and 33 with nHCM.
In the oHCM group, EDG-7500 produced reductions in LVOT-G at rest and following Valsalva maneuver, with 90% of patients showing improvement in hemodynamic measures. The company also reported that 74% of patients either achieved NT-proBNP normalization, defined as less than 150 pg/mL, or experienced a reduction of at least 50% from baseline.
Patients with oHCM recorded a mean 24-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), while 70% showed at least one class improvement in New York Heart Association (NYHA) functional classification. The treatment was also associated with an approximately 20% mean increase in early diastolic mitral annular velocity (e’ lateral). In a high-frame-rate sub-study, E/e’ improved by a mean of 5.3 points.
Among patients with nHCM, investigators reported an approximately 65% mean reduction in NT-proBNP. A total of 88% of patients achieved either normalization of NT-proBNP or at least a 50% reduction from baseline. The group recorded a 13-point mean increase in KCCQ-OSS, and 64% of participants experienced at least one class improvement in NYHA classification.
The newly reported 12-week nHCM results followed previously released four-week data in which Edgewise reported improvements of up to 22 points on the KCCQ. Additional findings included a 37% mean increase in e’ lateral and a mean 6.1-point improvement in E/e’ in the high-frame-rate sub-study.
Safety data showed that EDG-7500 was generally well tolerated. Nearly all adverse events were mild to moderate in severity, and no new safety signals were identified. There were no meaningful changes in left ventricular ejection fraction (LVEF), and no reductions in LVEF below 50% were observed. Two new-onset atrial fibrillation events occurred during the study; both were deemed unrelated to the study drug by investigators.
Commenting on the findings, Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise Therapeutics, said: “These Phase 2 data mark an important milestone for Edgewise and the HCM community, reinforcing EDG-7500’s unique approach with the potential to address diastolic dysfunction across HCM without meaningful impact on LVEF.”
Matthew Martinez, M.D., President of the HCM Society, said the Phase 2 efficacy and tolerability data continue to support a differentiated profile for EDG-7500 across hypertrophic cardiomyopathy.
During an analyst call discussing the results, Koch also said that the opportunity in hypertrophic cardiomyopathy is to move EDG-7500 into community cardiology settings where physicians do not want to perform multiple echocardiograms, noting that monitoring requirements can affect prescribing practices for currently available therapies.
Edgewise Therapeutics has announced positive Phase 2 results from the CIRRUS-HCM clinical trial evaluating EDG-7500 for hypertrophic cardiomyopathy (HCM). The encouraging findings provide Edgewise with important clinical evidence as the company prepares for planned Phase 3 development. The results reinforce Edgewise’s strategy of developing targeted therapies for serious muscle and cardiovascular diseases.
Overview of the CIRRUS-HCM Phase 2 Study
The Edgewise CIRRUS-HCM trial was designed to assess the safety, tolerability, pharmacokinetics, and clinical activity of EDG-7500 in patients with hypertrophic cardiomyopathy. Researchers evaluated multiple endpoints to determine whether the investigational therapy could improve cardiac function while maintaining an acceptable safety profile. The positive data provide a strong foundation for the next stage of development.
Strengthening the Edgewise Clinical Pipeline
The positive CIRRUS-HCM results represent another important achievement for Edgewise as it expands its pipeline of precision therapies. Continued investment in cardiovascular research demonstrates the company’s commitment to developing innovative medicines for diseases with significant unmet medical needs.
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