Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions by Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease and Assistant Professor of Medicine at the University of Pennsylvania.
A new analysis from SEQUOIA-HCM showed that treatment with aficamten was associated with beneficial changes in five indices reflecting structural, electrophysiologic and biomarker changes in patients from SEQUOIA-HCM. This analysis was performed in patients treated with aficamten and compared to placebo, at 24 weeks as follows:
- Improvement in maximal wall thickness by ≥1.5 mm (n = 282; 47.9% vs 30.7%; p=0.003)
- Improvement in left atrial volume index (LAVI) category in those with mild, moderate, or severe enlargement at baseline (n = 185; 46.8% vs. 18.7%; p<0.001)
- Resolution of ECG changes consistent with left ventricular hypertrophy (n = 282; 19.0% vs. 4.3%; p<0.001)
- Normalization of hyperdynamic left ventricular ejection fraction (defined as ≥72%) into the normal range (n = 282; 35.2% vs 20.7%; p<0.007)
- Reduction in NT-proBNP by ≥50% from baseline (n = 282; 81.7% vs. 7.1%; p<0.001).
Overall, 83.8% of patients treated with aficamten experienced favorable effects in at least one of the five domains, compared to 39.3% of patients on placebo (p<0.001, NNT = 2.2).