Cytokinetics paves the way for a mid-stage trial of a heart failure drug following encouraging data from Phase 1 study

Monday, Cytokinetics, Incorporated (NASDAQ: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 of evaluating the safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of CK-586.

CK-586 is an investigational cardiac myosin inhibitor for the potential treatment of a subset 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 study discontinuation criteria were not met.

The half-life of CK-586 was in the range of 14 to 17 hours.

CK-586 demonstrated dose linearity with no change in half-life over a wide exposure range, reaching steady state within seven days of administration.

Left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) decreased from baseline in a exposure-dependent manner, and the pharmacokinetic/pharmacodynamic (PK/PD) relationship appeared small and predictable.

Ejection fraction measures how well the heart is functioning. It is expressed as a percentage and indicates how much blood the heart pumps with each contraction. At the highest single dose of 600 mg, the mean decrease in LVEF was

These results demonstrate pharmacological 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 ongoing and the trial is expected to start in the fourth quarter of 2024.

Price promotion: CYTK shares were up 2.71% to $55.56 at last check on Monday.

Photo via Shutterstock

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This article Cytokinetics sets the stage for mid-stage trial of heart failure drug after encouraging Phase 1 trial data originally appeared on Benzinga.com

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