Cytokinetics Announces Topline Data From Phase 1 Clinical Study of CK-4021586

Data Support Advancement to Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024

Full Data from the Phase 1 Study to be Presented at a Medical Congress in 2H 2024

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline data from the Phase 1 study of CK-4021586 (CK-586). The study met its primary and secondary objectives to assess the safety, tolerability and pharmacokinetics (PK) 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 (HFpEF) 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.

“These data reinforce the potential of CK-586 as a drug candidate designed to directly impact the underlying hypercontractility in a subset of patients with HFpEF,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President, Research and Development. “Based on previously reported positive Phase 2 results of aficamten in patients with non-obstructive HCM, we are confident in this approach in HFpEF as the conditions have a similar profile. We look forward to starting the Phase 2 clinical trial of CK-586 in the fourth quarter, further extending the potential of our cardiac myosin directed development platform focused to specialty cardiology indications.”

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 design included seven single ascending dose cohorts (10 mg to 600 mg) comprised of 10 participants each, and two multiple-dose ascending cohorts (100 and 200 mg once daily) comprised of 10 participants each. 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.