Cytokinetics opens enrollment in CEDAR-HCM trial of aficamten in pediatric obstructive HCM

CYTOKINETICS INC

Initial cohort ~40 adolescents (12-17) with LVEF ≥60%, Valsalva LVOT-G ≥50 mmHg, NYHA ≥II.
Dosing starts at 5 mg once daily; up-titration at Wk2/4/6 to 10/15/20 mg based on Valsalva LVOT-G ≥30 mmHg and LVEF ≥55%.
Primary endpoint: change in Valsalva LVOT-G at Week 12; secondary endpoints include resting LVOT-G, NYHA class, PK, NT-proBNP, hs-cTnI.
Second cohort of ~8-10 patients aged 6-11 will open after data from ≥20 adolescents complete Week 12.

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