Cytokinetics Presents Additional Data From SEQUOIA-HCM at the European Society of Cardiology Congress 2024

Additional Data from SEQUOIA-HCM Demonstrate Favorable Cardiac Remodelingby Cardiac MRI, Improvements in Cardiac Structure and Function by Echocardiography,Symptom Relief and Improvement in Biomarkers with Aficamten

Presentations Accompanied by Four Simultaneous Journal Publications

Company to Host Conference Call and Webcast Tuesday, September 3rd at 8:00 AM Eastern Time

SOUTH SAN FRANCISCO, Calif., Sept. 01, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), related to cardiac remodeling and improvements in patient symptoms, cardiac structure, function and biomarkers, were presented in three Late Breaking Clinical Trial presentations and one oral presentation at the European Society of Cardiology Congress 2024 in London, UK. These presentations were accompanied by simultaneous publications in leading cardiac journals, three in the Journal of the American College of Cardiology and one in the European Heart Journal.

“As we continue to dissect data from SEQUOIA-HCM, the expanding body of evidence reinforces the effects of aficamten on clinical outcomes, symptom burden, cardiac biomarkers and cardiac structure and function,” said Stephen Heitner, M.D., Vice President, Head of Clinical Research. “Key data presented and published today show that treatment with aficamten appears to improve the architecture of the heart in patients with obstructive HCM, suggesting potential for disease modification. These data reinforce the primary analyses of SEQUOIA-HCM which are central to our rolling NDA submission for aficamten expected to be completed during this third quarter.”

Data from SEQUOIA-HCM CMR Sub-Study Show Treatment with Aficamten is Associated with Favorable Cardiac Remodeling

Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University presented data from the cardiac magnetic resonance (CMR) sub-study in SEQUOIA-HCM. The data were simultaneously published in Journal of the American College of Cardiology.1 Of the 282 patients with obstructive HCM who participated in SEQUOIA-HCM, 57 patients participated in the CMR-sub-study and 50 patients completed the study, including 21 patients who received aficamten and 29 patients who received placebo. Baseline characteristics of patients enrolled in the CMR sub-study were comparable to the overall patient population in SEQUOIA-HCM. The primary endpoint in the CMR sub-study was the change from baseline to Week 24 in left ventricular mass index (LVMI) from baseline. Treatment with aficamten significantly improved LVMI (-15.4 g/m2, p=0.001) and resulted in favorable cardiac remodeling as demonstrated by reductions in left ventricular maximal wall thickness (p