Cytokinetics Presents New Data Related to Aficamten at the HFSA Annual Scientific Meeting 2025

Core Insights - Aficamten shows significant improvements in exercise capacity and recovery compared to metoprolol in patients with obstructive hypertrophic cardiomyopathy (oHCM) and demonstrates long-term efficacy and tolerability in non-obstructive hypertrophic cardiomyopathy (nHCM) patients [1][2][6] Group 1: MAPLE-HCM Study Findings - Aficamten demonstrated a statistically significant improvement in peak oxygen uptake (pVO2) with a treatment difference of +2.3 mL/kg/min (p<0.001) compared to metoprolol [3] - Additional analyses revealed improvements in submaximal exercise performance, including anaerobic threshold (+76 mL, p<0.001) and aerobic efficiency (+0.8 mL/min/watt, p=0.004) [4][5] - Aficamten also improved post-exercise recovery metrics, with a faster VO2 recovery rate compared to metoprolol [3] Group 2: FOREST-HCM Study Findings - In the FOREST-HCM study, 79% of patients with nHCM improved by at least one NYHA Functional Class after 96 weeks of treatment, with 74% becoming asymptomatic [7] - Aficamten led to a mean increase of 11.2 points in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [7] - Cardiac biomarkers such as NT-proBNP and high-sensitivity cardiac troponin I showed significant declines by Week 12 and remained low through Week 96 [7] Group 3: Aficamten Overview - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM) [9] - The drug is currently under evaluation in multiple clinical trials, including ACACIA-HCM for nHCM and CEDAR-HCM for pediatric patients with oHCM [11] - Aficamten has received Breakthrough Therapy Designation from the FDA for symptomatic HCM and is undergoing regulatory review in the U.S., Europe, and China [13]