Cytokinetics presents aficamten data at cardiology congress
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Cytokinetics, Incorporated (NASDAQ: CYTK) presented additional data on aficamten at the European Society of Cardiology Congress 2025 in Madrid. The data included results from the MAPLE-HCM trial comparing aficamten to metoprolol, and an analysis of atrial fibrillation incidence in patients treated with the investigational drug.
In the MAPLE-HCM trial, aficamten demonstrated superiority over metoprolol in improving measures of diastolic function and reducing mitral valve systolic anterior motion. The treatment showed a significant decrease in maximal wall thickness compared to metoprolol, with a treatment difference of -1.01 mm. One patient treated with aficamten experienced transient left ventricular ejection fraction below 50% without heart failure or treatment interruption.
A separate analysis examined atrial fibrillation incidence among 173 patients followed for at least 48 weeks in the FOREST-HCM study. Among 136 patients with no history of atrial fibrillation at baseline, four patients developed new-onset atrial fibrillation during follow-up, representing an annual incidence rate of 1.5%. This rate aligns with expected rates from prediction models for patients with hypertrophic cardiomyopathy.
The FOREST-HCM study enrolled 296 patients with obstructive hypertrophic cardiomyopathy from May 2021 through August 2024, providing 352 patient-years of cumulative exposure to aficamten over a mean follow-up of 62 weeks. Treatment resulted in significant reduction in left ventricular outflow tract gradient by Week 12, which was sustained through long-term treatment.
Aficamten is currently under regulatory review in the United States, with the FDA reviewing a New Drug Application with a target action date of December 26, 2025. The company will host an investor webcast on September 2, 2025, to discuss the results.
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