Cytokinetics Presents Additional Data From SEQUOIA-HCM at the European Society of Cardiology Congress 2024

Core Insights - Cytokinetics announced favorable results from the SEQUOIA-HCM trial, demonstrating that aficamten significantly improves cardiac remodeling, structure, function, and patient symptoms in individuals with symptomatic obstructive hypertrophic cardiomyopathy (HCM) [1][2][3] Clinical Trial Results - The SEQUOIA-HCM trial presented data showing that aficamten treatment led to a significant reduction in left ventricular mass index (LVMI) by -15.4 g/m² (p=0.001) and improvements in left ventricular maximal wall thickness, left atrial volume index, and extracellular volume mass index [3][4] - Aficamten improved echocardiographic measures, including a 60% reduction in left ventricular outflow tract gradient (LVOT-G) and no adverse changes in left ventricular ejection fraction (LVEF) [5][6] - The treatment resulted in significant improvements in patient-reported outcomes, with a 7.9-point increase in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) and a 7.8-point increase in the Seattle Angina Questionnaire Summary Score (SAQ-SS) [7][8] Biomarker Improvements - Aficamten treatment led to an 80% reduction in NT-proBNP and a 43% reduction in high-sensitivity cardiac troponin (hs-cTnI), both significant indicators of cardiac stress and injury [9][10] - Improvements in NT-proBNP were associated with enhanced exercise capacity and symptom relief, indicating its potential as a monitoring tool for treatment response [9][10] Future Developments - Cytokinetics plans to submit a New Drug Application (NDA) for aficamten to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024 [12][15] - The company is also conducting additional studies, including the MAPLE-HCM trial and the ACACIA-HCM trial, to further evaluate aficamten's efficacy in different patient populations [13][15]