Edgewise Therapeutics Inc. (EWTX) had a very good Wednesday, with shares climbing nearly 18% after the company shared encouraging updates from its ongoing CIRRUS-HCM Phase 2 trial testing EDG-7500 in patients with hypertrophic cardiomyopathy.
Here's what makes this interesting: EDG-7500 is an oral cardiac sarcomere modulator, which is a fancy way of saying it's designed to slow early contraction velocity and improve cardiac relaxation in patients with HCM without messing up systolic function. That's important because you want to help the heart relax better without compromising its ability to pump blood effectively.
Earlier this year, Edgewise reported topline results from Parts B and C of the trial, which tested 50 mg and 100 mg fixed doses in patients with obstructive HCM (17 participants) and non-obstructive HCM (12 participants). Now the company has added data from a lower 25 mg dose tested in 4 obstructive HCM patients and 10 non-obstructive HCM patients.
The results look promising across the board. The drug showed evidence of clinical activity across key HCM disease markers while maintaining a favorable safety profile. Critically, there were no clinically meaningful changes in left ventricular ejection fraction (LVEF), which measures how well the heart pumps blood with each beat. No patients saw their LVEF drop below 50%, and there were no cases of atrial fibrillation.
Parts B and C of the CIRRUS-HCM trial have now completed dosing, with 43 participants enrolled across all dose groups.
Looking Ahead
The trial is now in Part D, which is designed to explore exposure-response correlations and assess biomarker-guided dose optimization. This phase will help inform the design of Phase 3 trials and support regulatory discussions with the FDA.
In an interim safety update, 20 participants who completed 12 weeks of dosing in Part D (8 with obstructive HCM and 12 with non-obstructive HCM) showed that EDG-7500 generally had a favorable safety profile and was well tolerated. Consistent with earlier observations, there were no clinically significant changes in LVEF or reductions below 50%.
What's particularly notable is that EDG-7500 continues to demonstrate a differentiated LVEF profile compared to cardiac myosin inhibitors (CMIs), the existing class of drugs used to treat this condition. The safety profile observed across both healthy volunteers and the CIRRUS-HCM trial suggests EDG-7500 could potentially be used in diverse HCM patient populations.
Edgewise remains on track to deliver comprehensive efficacy and safety data from Part D of the trial in the second quarter of 2026 and is advancing Phase 3 trial design in preparation for trial initiation by the end of 2026.
The Competitive Context
The timing of this update is interesting. Earlier this week, the FDA approved Cytokinetics Incorporated's (CYTK) Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. So Edgewise is chasing a competitor that just crossed the finish line, but the company's differentiated safety profile could give it an edge in capturing market share down the road.
Edgewise Therapeutics shares were up 17.96% at $25.65 at the time of publication on Wednesday.
