Cytokinetics Shares Aficamten Safety Data at ESC Congress 2024

Cytokinetics, Incorporated has recently showcased new data on the safety and long-term use of aficamten at the European Society of Cardiology Congress 2024 in London, UK. This new information stems from an integrated safety analysis of three clinical studies involving aficamten and an evaluation of the withdrawal of standard of care (SoC) medications in patients treated with aficamten in the FOREST-HCM study. The findings suggest that aficamten is well-tolerated and has a promising safety profile, which could make it a preferred cardiac myosin inhibitor for real-world applications.

Dr. Stephen Heitner, Vice President and Head of Clinical Research at Cytokinetics, emphasized the importance of these findings. He noted that the data supports aficamten's potential as a cardiac myosin inhibitor, highlighting its safety and tolerability. Additionally, the research showed that patients could successfully withdraw from background SoC medications, often simplifying their treatment to aficamten monotherapy. This withdrawal did not adversely affect the safety or efficacy of aficamten, indicating that the drug could be effective as a standalone treatment for hypertrophic cardiomyopathy (HCM).

Ahmad Masri, M.D., M.S., Director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University, presented the integrated safety analysis data. This analysis pooled results from the Phase 2 REDWOOD-HCM trial, the Phase 3 SEQUOIA-HCM trial, and the open-label extension study FOREST-HCM. In total, 283 patients received at least one dose of aficamten, and 153 received a placebo. The results were encouraging, showing that aficamten was well-tolerated with an adverse event profile similar to that of the placebo. Only 3.9% of patients experienced a left ventricular ejection fraction (LVEF) of less than 50%, none of which were associated with clinical heart failure and were managed successfully by dose adjustments.

Furthermore, the study reported low incidences of new onset atrial fibrillation and myocardial infarction among aficamten-treated patients compared to those on placebo. The rate of syncope events was also similar between the two groups. These findings bolster the safety profile of aficamten, making it a viable option for managing HCM in real-world settings.

In another presentation, Dr. Masri discussed the withdrawal of SoC medications in patients with obstructive HCM treated with aficamten. Out of 145 patients who completed at least 24 weeks of treatment, 136 were on SoC medications. Withdrawal attempts were made in 64 patients at the discretion of the investigators, and 59 of these attempts were successful. This included 38 patients who discontinued at least one SoC medication and 27 who achieved and maintained aficamten monotherapy. Importantly, the withdrawal of SoC medications did not negatively impact the efficacy or safety of aficamten, as there were no significant differences in key cardiac metrics or adverse events between those who withdrew from SoC medications and those who did not.

The data indicate that aficamten could be a reliable monotherapy for obstructive HCM, warranting further investigation. Cytokinetics plans to continue evaluating aficamten's potential, with ongoing studies such as MAPLE-HCM, which compares aficamten as a monotherapy to metoprolol in patients with obstructive HCM, and ACACIA-HCM for non-obstructive HCM.

In summary, the new data presented by Cytokinetics underscore aficamten's robust safety profile and its potential as a monotherapy for patients with hypertrophic cardiomyopathy. These findings pave the way for further studies and potential future applications in clinical settings.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!