Cytokinetics Announces Data From Phase 1 Study of CK-4021586
Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from the Phase 1 study of CK-4021586 (CK-586) were presented in a poster session at the American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD. 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 symptomatic HFpEF with hypercontractility and ventricular hypertrophy.
“The results from this Phase 1 study replicate pre-clinical findings that show CK-586 directly reduces cardiac contractility at the level of the sarcomere. Importantly, CK-586 was observed to have a shallow and predictable PK/PD relationship and half-life that enables a once-daily fixed dosing regimen in patients with HFpEF,” said Stuart Kupfer, M.D., Senior Vice President, Chief Medical Officer. “Preparations are underway for a Phase 2 clinical trial of CK-586 in a subset of patients with HFpEF that we plan to start in the fourth quarter.”
Phase 1 Design and Key Findings
The primary objective of this Phase 1 double-blind randomized, placebo-controlled, single and multiple ascending dose clinical study was to evaluate the safety, tolerability and PK of CK-586 when administered orally 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 cohorts (100 and 200 mg once daily) comprised of 10 participants each.
This study data demonstrated that CK-586 was safe and well tolerated in healthy participants. No serious adverse events were observed and the stopping criteria for the study were not met. The half-life of CK-586 was observed to be in the range of 14 to 17 hours. CK-586 demonstrated dose-linearity without a change in half-life over a wide range of exposures, with steady state appearing evident within seven days of dosing. Left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) decreased from baseline in an exposure-dependent manner, and the pharmacokinetic/pharmacodynamic (PK/PD) relationship appeared shallow and predictable (Figure 1). At the highest single dose of 600 mg, the mean decrease in LVEF was
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