Cytokinetics launches real-world study of aficamten in heart disease

Cytokinetics, Incorporated (Nasdaq: CYTK) announced the launch of ASPEN-HCM, a prospective, multicenter, observational real-world study evaluating its cardiac drug MYQORZO (aficamten) in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), according to a press release.

Led by the University of California, San Francisco, the study will span 13 cardiology practices and HCM centers of excellence, aiming to enroll approximately 400 patients over an anticipated 12-to-36-month period. The study will assess the real-world safety profile, clinical effectiveness, and economic impact of MYQORZO in routine clinical practice.

Key endpoints include reductions in left ventricular ejection fraction, treatment discontinuations, changes in left ventricular outflow tract gradient, New York Heart Association classification, and patient-reported outcomes. Secondary objectives include analyzing healthcare resource utilization, hospitalization and procedure rates, and cardiac structural remodeling.

The study will also examine longitudinal treatment patterns, dose titration, atrial fibrillation prevalence, and whether MYQORZO delays or avoids the need for invasive septal reduction therapy.

MYQORZO is a once-daily oral cardiac myosin inhibitor approved in the U.S., China, European Union, and United Kingdom for treatment of symptomatic oHCM. The drug carries a boxed warning for the risk of heart failure due to systolic dysfunction and is available only through a restricted Risk Evaluation and Mitigation Strategy program. Hypertension was reported as an adverse reaction in 8% of patients on MYQORZO versus 2% on placebo in the pivotal trial.

"The clinical trials we conducted of MYQORZO provided strong evidence supporting its approval," said Sanatan Shreay, Ph.D., Cytokinetics' Executive Director, Head of Health Economics and Outcomes Research. "Now, this study will build on that foundation by generating valuable real-world insights that can help inform clinical decision-making."

Cytokinetics also stated it plans to submit a Supplemental New Drug Application for aficamten in non-obstructive HCM in the fourth quarter of 2026, following positive Phase 3 results in the ACACIA-HCM trial.

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