Edgewise Therapeutics announced that dosing in Parts B (obstructive hypertrophic cardiomyopathy, n = 17) and Parts C (non‑obstructive HCM, n = 12) of its CIRRUS‑HCM Phase 2 study has been completed, bringing the total enrollment across all dose groups to 43 participants. Interim safety data from Part D, which explores exposure‑response relationships and dose optimization, show that more than 40 participants have been enrolled and that 70 % of those who reached a dose of 100 mg or higher have completed 12 weeks of treatment. No clinically meaningful reductions in left‑ventricular ejection fraction or atrial fibrillation events were observed, confirming the drug’s safety profile and its ability to preserve systolic function.
The safety findings are particularly noteworthy because EDG‑7500 is designed to slow early contraction velocity and improve cardiac relaxation without impairing systolic function—a key differentiator from other cardiac myosin inhibitors that can reduce ejection fraction. The absence of atrial fibrillation events, a known safety concern for this drug class, further strengthens the case for continued development. With 20 participants in Part D having completed 12 weeks, the data set is robust enough to support the next phase of the program.
Edgewise plans to deliver comprehensive efficacy and safety data from Part D in the second quarter of 2026 and to finalize the Phase 3 trial design in preparation for initiation by the end of 2026. The company’s progress in the HCM program represents a strategic expansion of its platform beyond muscular dystrophy, positioning EDG‑7500 as a potential first‑in‑class oral therapy for a disease that affects roughly one in 500 people. The company’s strong balance sheet—more cash than debt and low leverage—provides the financial flexibility to fund the upcoming Phase 3 studies while maintaining investment in its muscular dystrophy pipeline.
Investor reaction to the announcement was positive, driven by the favorable safety data and the clear path toward Phase 3. Analysts highlighted the lack of significant left‑ventricular ejection fraction decline and the absence of atrial fibrillation events as key differentiators that could give EDG‑7500 a competitive edge. However, some analysts noted lingering safety concerns, particularly the single new‑onset atrial fibrillation case in Part D, which underscores the need for longer‑term data to fully address regulatory and market acceptance.
Kevin Koch, President and CEO of Edgewise, said the company is “excited by the safety profile of EDG‑7500 and the progress in the CIRRUS‑HCM program.” He added that the company will focus on refining the development strategy to deliver the drug’s best‑in‑disease potential for HCM patients while continuing to expand its platform across muscle diseases.
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