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New Heart Drug Shows Promising HCM Trial Results
17 Jun
Summary
- EDG-7500 trial demonstrates positive results in hypertrophic cardiomyopathy patients.
- The drug improved key hemodynamic and biomarker measures in obstructive HCM.
- EDG-7500 was well-tolerated with mostly mild to moderate adverse events.
Edgewise Therapeutics has reported encouraging results from the Phase II CIRRUS-HCM trial for its experimental cardiac drug, EDG-7500. This therapy is designed for patients suffering from both obstructive (oHCM) and non-obstructive (nHCM) forms of hypertrophic cardiomyopathy.
The trial's Part D, which was a 12-week open-label study, focused on assessing EDG-7500's potential to modulate cardiac function. The drug's primary aim was to slow early contraction velocity and enhance cardiac relaxation without negatively impacting systolic function.
Results in patients with oHCM showed significant reductions in left ventricular outflow tract gradient and broad clinical improvements. Approximately 74% of these patients achieved either biomarker normalization or a substantial drop from baseline. Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire, saw a notable increase.
For nHCM patients, the trial indicated an average reduction of 65% in N-terminal pro-B-type natriuretic peptide levels. A majority experienced improved functional class and cardiac relaxation markers. EDG-7500 was found to be generally well-tolerated across all participants, with side effects reported as mostly mild to moderate.
Edgewise Therapeutics plans to launch a Phase III program in the fourth quarter of 2026, based on these positive Phase II findings. The CIRRUS-HCM trial is currently being conducted at over 20 clinical sites throughout the United States.
