Edgewise Therapeutics Reports Positive Phase 2 Progress for EDG-7500 in Hypertrophic Cardiomyopathy

Edgewise Therapeutics Reports Positive Phase 2 Progress for EDG-7500 in Hypertrophic Cardiomyopathy

By, Admin 30 December 2025

Edgewise Therapeutics has shared encouraging interim updates from its ongoing CIRRUS-HCM Phase 2 trial evaluating EDG-7500, a novel oral therapy for hypertrophic cardiomyopathy (HCM).

The data reinforce EDG-7500’s potential as a differentiated treatment that improves cardiac relaxation without compromising systolic function, a key limitation of existing therapies.

Why EDG-7500 Matters in HCM?

Hypertrophic cardiomyopathy is driven by excessive cardiac contraction and impaired relaxation. Many current therapies risk reducing left ventricular ejection fraction (LVEF).

EDG-7500 is designed to:

  • Slow early cardiac contraction velocity
  • Improve diastolic relaxation
  • Preserve systolic function

This combination directly targets two central goals in HCM management.

CIRRUS-HCM Trial Overview

CIRRUS-HCM is a multi-part, open-label Phase 2 study enrolling patients with:

  • Obstructive HCM (oHCM)
  • Nonobstructive HCM (nHCM)

The trial evaluates multiple fixed and optimized doses of EDG-7500.

Key Findings From Parts B and C

Earlier cohorts tested 25 mg, 50 mg, and 100 mg fixed doses.

Across these groups, EDG-7500 showed improvements in core HCM markers:

  • NT-proBNP reductions, indicating improved cardiac stress
  • KCCQ score improvements, suggesting better quality of life
  • NYHA class improvements, reflecting functional gains
  • LVOT gradient reductions in obstructive HCM patients

Importantly:

  • No clinically meaningful LVEF reductions were observed
  • No LVEF values dropped below 50%
  • No atrial fibrillation events were reported

Part D: Dose Optimization and Safety Focus

Part D is designed to:

  • Explore exposure–response relationships
  • Optimize dosing using biomarkers
  • Inform Phase 3 trial design

Participants receive doses ranging from 25 mg to 150 mg, with potential escalation to 200 mg.

As of the December 23, 2025 cutoff:

  • Over 40 patients enrolled
  • ~70% reached 100 mg or higher
  • Dosing guided by LVOT-G (oHCM) and NT-proBNP (nHCM)

Strong Safety Signal Continues

Among the first 20 participants completing 12 weeks in Part D:

  • EDG-7500 remained well tolerated
  • No clinically significant LVEF declines
  • No detected atrial fibrillation or flutter during monitored periods

Over 2,600 patient-days of cardiac monitoring showed no clinically meaningful arrhythmias. One AF event occurred off-monitoring and was deemed unrelated to treatment.

How EDG-7500 Stands Apart From CMIs?

Unlike cardiac myosin inhibitors (CMIs), EDG-7500:

  • Does not impair systolic function
  • Avoids intensive cardiac safety monitoring burdens
  • May be suitable beyond specialty HCM centers

This profile could significantly expand patient access if approved.

What’s Next for Edgewise?

Edgewise plans to:

  • Report full Part D efficacy and safety data in Q2 2026
  • Finalize Phase 3 trial design
  • Initiate Phase 3 studies by end of 2026

The Bigger Picture: Unmet Need in HCM

HCM affects 1 in 500 people globally. Patients often face breathlessness, fatigue, arrhythmias, and reduced quality of life. Despite recent advances, many patients still lack optimal treatment options.

EDG-7500 aims to change that equation.

Bottom Line

EDG-7500 continues to demonstrate:

  • Consistent clinical improvements
  • A differentiated safety profile
  • Strong potential as a best-in-disease therapy

If these results hold in Phase 3, EDG-7500 could redefine how both obstructive and nonobstructive HCM are treated.

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