Cytokinetics Announces Start of ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Expanding Development Program to Assess Potential of Aficamten in Additional Patient Population to Inform Increased Utility of Cardiac Myosin Inhibition

SOUTH SAN FRANCISCO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), is open to enrollment. Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM.

“As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “ACACIA-HCM builds on the encouraging findings from Cohort 4 of REDWOOD-HCM, the Phase 2 clinical trial which demonstrated that treatment with aficamten resulted in statistically significant improvements in heart failure symptoms and cardiac biomarkers in patients with non-obstructive HCM. In ACACIA-HCM we look forward to assessing the impact of aficamten in patients with non-obstructive HCM on symptoms and quality of life as well as on other measures of disease burden, including exercise capacity, functional class, cardiac structure and function and cardiovascular outcomes.”

ACACIA-HCM: Clinical Trial Design

ACACIA-HCM is a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo on health-related quality of life in participants with symptomatic nHCM. The primary endpoint is the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score from baseline to Week 36. Secondary endpoints include the change from baseline to Week 36 in maximal exercise performance (peak VO₂) and sub-maximal exercise performance (Ve/VCO₂), the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class, changes in left atrial volume index (LAVI) and NT-proBNP. After the primary analysis at 36 weeks, patients will continue treatment with aficamten or placebo for up to 72 weeks to evaluate additional secondary and exploratory analyses including the time to first cardiovascular event.