Slide 1: EDG-15400 Demonstrated Favorable Pharmacokinetics, Pharmacodynamics, and Tolerability in Healthy Adults
EDG-15400, An Investigational Cardiac Sarcomere Modulator, Demonstrated Favorable Pharmacokinetics, Pharmacodynamics, and Tolerability in Healthy Adult Participants Marilyn Mok, PhD Associate Director, DMPK Edgewise Therapeutics
Slide 2: Presentation Background
Presentation Background • The following slides were presented as part of HFSA’s 2026 Oral Abstract Rapid Fire session where presenters had 5 minutes for the oral update and 2 minutes of Q&A to share their findings.
Slide 3: First-in-Human Phase 1 Study of EDG-15400 in HFpEF
First-in-Human Phase 1 Study of EDG-15400, An Investigational Novel Cardiac Sarcomere Modulator, in Heart Failure with Preserved Ejection Fraction • HFpEF is a syndrome of heart failure in which LVEF is preserved, but EDG-15400-101 Study Design ventricular relaxation and filling are impaired • EDG-1
Slide 4: EDG-15400 Rapidly Absorbed and Well-Tolerated with No Food Effect
EDG-15400 was Rapidly Absorbed and Well-Tolerated with No Food Effect 10000 Steady-state ~8 days 1000 TEAEs after multiple ascending doses of EDG-15400 100 10 EDG-15400 QD PO x 14 Days 10 mg 20 mg 40 mg 80 mg 1 0 48 96 144 192 240 288 Time (h) 1000 Plasma Concentration (ng/mL) 100 EDG-15400 10 50 mg
Slide 5: Summary
Summary • EDG-15400 was well-tolerated • No clinically meaningful changes or trends in clinical chemistry, hematology, ECGs, or echocardiograms (no significant decrease in LVEF) • EDG-15400 exhibited favorable once-daily dosing properties • Dose-proportional and linear PK • No food effect • EQUINOX-
Slide 6: Acknowledgements
Acknowledgements Edgewise Therapeutics thanks all the study participants, site investigators, and site personnel for their involvement in our clinical studies.