Cytokinetics Announces Additional Results From SEQUOIA-HCM Presented in Late Breaking Clinical Trial Session at the European Society of Cardiology Heart Failure 2024 Congress

Analyses of SEQUOIA-HCM Elaborate on Dosing and Measures of Safety During Treatment with Aficamten

Results from Cardiopulmonary Exercise Testing Showed Improvement in Exercise Performance were Strongly Correlated to Other Measures of Clinical Improvement

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SOUTH SAN FRANCISCO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results 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), elaborating on dosing and safety data as well as the effect of aficamten on exercise performance were presented at Heart Failure 2024, an International Congress of the European Society of Cardiology. The primary results from SEQUOIA-HCM were also presented in the same Late Breaking Clinical Trial session at the Congress and simultaneously published in the New England Journal of Medicine.¹

“These additional analyses from SEQUOIA-HCM further illuminate the positive impact of treatment with aficamten on measures of dosing, safety, efficacy and impact on quality of life beyond the primary and secondary endpoints of the trial,” said Stuart Kupfer, M.D., SVP, Chief Medical Officer. “Notably, the dosing and safety data support dose down-titration in cases of low left ventricular ejection fraction (LVEF), potentially enabling ease of individualized dosing for patients treated with aficamten and also may inform a tailored risk mitigation approach.”

Aficamten Demonstrates Predictable Dosing with No Dose Interruptions Due to LVEF <50%

Results from prespecified analyses from SEQUOIA-HCM on dosing and measures of safety during treatment with aficamten were presented by Caroline Coats, M.D., Ph.D., Lead Clinician, West of Scotland Inherited Cardiac Conditions Service, Honorary Senior Lecturer, School of Cardiovascular and Metabolic Health, University of Glasgow. In SEQUOIA-HCM, there were no major adverse cardiovascular events associated with treatment with aficamten. Serious adverse events occurred in 8 (5.6%) patients in the aficamten group and 13 (9.3%) patients in the placebo group, none of which were determined to be related to study drug. There was no difference in the incidence of adverse events by dose strength. Over the duration of the 24-week double-blind treatment period, patients treated with aficamten had a placebo-corrected average change in left ventricular ejection fraction (LVEF) of -4.8% (95% CI -6.3 to -3.2). This modest reduction in LVEF in patients treated with aficamten resulted in large reductions in left ventricular outflow tract gradient (LVOT-G).