Cytokinetics Sets Stage For Mid-Stage Study For Heart Failure Drug After Encouraging Data From Phase 1 Study

Monday, Cytokinetics, Incorporated CYTK 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 Annual Meeting in Bethesda, MD.

The study met its primary and secondary objectives to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple oral doses of CK-586.

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 study data showed 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.

The ejection fraction measures how well the heart is functioning. It's expressed as a percentage and indicates how much blood the heart pumps out with each contraction. At the highest single dose of 600 mg, the mean decrease in LVEF was <5%.

These results demonstrate pharmacologic properties that may enable once-daily fixed-dose administration in the future. Preparations for a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) are underway, and the trial is expected to begin in the fourth quarter of 2024.

Price Action: CYTK stock is up 2.71% at $55.56 at last check Monday.

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