Cytokinetics aficamten shows cardiac benefits in two HCM trial analyses
Cytokinetics, Incorporated (Nasdaq: CYTK) announced additional results from two Phase 3 clinical trials of aficamten at the European Society of Cardiology Congress 2026 in Munich, Germany, with findings simultaneously published in Circulation and the Journal of the American College of Cardiology: Heart Failure.
A pre-specified exploratory analysis of the ACACIA-HCM trial, which studied aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), showed improvements in cardiac structure and diastolic function beyond the previously reported gains in exercise capacity and symptom burden. At 36 weeks and at end of treatment, aficamten significantly improved measures of diastolic function including peak E velocity and septal e' velocity. Left ventricular wall thickness decreased by 0.2 cm at end of treatment, while left ventricular ejection fraction declined modestly but remained within normal range.
A post-hoc analysis of the MAPLE-HCM trial, which compared aficamten to metoprolol in 175 patients with symptomatic obstructive HCM, found that aficamten outperformed metoprolol on peak oxygen uptake regardless of whether patients had previously been taking beta blockers. Among patients not previously on beta blockers, the least squares mean difference in peak VO2 was +3.1 mL/kg/min (p<0.001), compared with +1.9 mL/kg/min (p<0.001) for those previously on beta blockers, with no statistically significant difference between the two groups. Aficamten also demonstrated consistent improvements over metoprolol on secondary endpoints including KCCQ Clinical Summary Score, NYHA Functional Class, LVOT gradient, and NT-proBNP. No differences in safety profiles between pre-trial treatment groups were observed.
Aficamten, marketed as MYQORZO, is approved in the U.S., China, European Union, and United Kingdom for symptomatic obstructive HCM. Cytokinetics said it plans to submit a Supplemental New Drug Application for the non-obstructive HCM indication in the fourth quarter of 2026.
