Cytokinetics Presents New Data Related to the Safety and Long-Term Use of Aficamten at the European Society of Cardiology Congress 2024

 Data from Integrated Safety Analysis Across Three Clinical TrialsReinforces Robust Safety Profile of Aficamten

Analysis from FOREST-HCM Demonstrates Successful Withdrawal of Standard of Care Medications in Patients with Obstructive HCM Treated with Aficamten

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SOUTH SAN FRANCISCO, Calif., Sept. 01, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data related to the safety and long-term use of aficamten were presented in a Late Breaking Clinical Trial presentation and oral presentation at the European Society of Cardiology Congress 2024 in London, UK. The presentations included an integrated safety analysis from three clinical studies of aficamten and an analysis of the withdrawal of standard of care medications in patients treated with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical study of aficamten in patients with hypertrophic cardiomyopathy (HCM).

“The emerging safety profile of aficamten observed across three clinical trials representing 206 patient years of exposure to aficamten provides a rationale for how aficamten may translate to real-world use as a cardiac myosin inhibitor of choice,” said Stephen Heitner, M.D., Vice President, Head of Clinical Research. “We’re encouraged by the promising safety and tolerability profile for aficamten as well as the observation that patients successfully withdrew background standard of care medications, with many able to simplify their treatment regimen to disease-specific monotherapy with aficamten. These findings were in an open-label setting, at the discretion of the patient and physician, and did not impact the safety or efficacy of aficamten. We look forward to results of MAPLE-HCM, the Phase 3 clinical trial assessing the potential superiority of aficamten as monotherapy compared to metoprolol, which we expect to disclose in the first half of next year.”

Integrated Safety Analysis from Three Clinical Trials of Aficamten Reinforces Robust Safety Profile

Ahmad Masri, M.D., M.S., Director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University presented data from an integrated safety analysis of aficamten across the Phase 2 clinical trial, REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 3 clinical trial, SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), and FOREST-HCM, the open-label extension clinical study of aficamten. Patients with obstructive HCM who received at least one dose of aficamten or placebo were included in this analysis. A total of 283 patients received at least one dose of aficamten and 153 patients received at least one dose of placebo. Overall, treatment with aficamten was well-tolerated with an adverse event profile similar to placebo. Across all three clinical studies, 11 patients (3.9%) experienced incidents of left ventricular ejection fraction (LVEF)