Cytokinetics announces study of CK-4021586 met primary, secondary objectives

Cytokinetics, Incorporated announced topline data from the Phase 1 study of CK-4021586. The study met its primary and secondary objectives to assess the safety, tolerability and pharmacokinetics of single and multiple oral doses of CK-586. The data support the advancement of CK-586 to a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction which is expected to begin in Q4 2024. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of patients with HFpEF. Phase 1 Design and Key Findings: The primary objective of this Phase 1 double-blind randomized, placebo-controlled, multi-part single and multiple ascending dose clinical study was to evaluate the safety, tolerability and PK of CK-586 when administered orally as single or multiple doses to healthy participants. The study met the primary objective, demonstrating that CK-586 was safe and well tolerated in healthy participants with linear PK. Pharmacodynamics were evaluated using echocardiography and consistent with expectations. No serious adverse events were observed, and the stopping criteria were not met in the study.