Cytokinetics, Incorporated has announced that primary results from Maple-HCM (Metoprolol vs Aficamten in patients with LVOT obstruction on exercise capacity in HCM) were presented in a hot line session at the European Society of Cardiology Congress 2025 in Madrid, Spain, and simultaneously published in The New England Journal of Medicine.1
Maple-HCM is a phase 3 randomised, double-blind, active-comparator clinical trial of Aficamten compared to metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive Aficamten or metoprolol as monotherapy. Compared to SEQUOIA-HCM, the pivotal phase 3 clinical trial of aficamten, MAPLE-HCM was designed to include patients with less severe oHCM, enrolling patients without obstruction at rest and with higher predicted peak oxygen uptake (pVO2).
Aficamten is an investigational drug candidate currently under regulatory review in the U.S; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of 26 December 2025.
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