SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4021586 (CK-586). CK-586 is a cardiac myosin inhibitor in development for the potential treatment of patients with heart failure with preserved ejection fraction (HFpEF).
“We are pleased to announce the initiation of the Phase 1 clinical study of CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “As a pioneer in the mechanics of cardiac myosin inhibition, we believe this mechanism may impact the underlying hypercontractility found in certain patients who have heart failure with preserved ejection fraction and look forward to pursuing this clinical hypothesis with CK-586.”
Phase 1 Clinical Trial Design
The primary objective of this Phase 1 randomized, double-blind, placebo-controlled, double-blind, multi-part single and multiple ascending dose clinical study is to evaluate the safety, tolerability and pharmacokinetics of CK-586 when administered orally as single or multiple doses to healthy participants. The study design includes up to eight single ascending dose cohorts comprised of 10 participants each, and four multiple-dose ascending cohorts comprised of 10 participants each. A final optional cohort will include twelve participants in an open-label, two-period crossover arm to investigate the effect of food on CK-586.