Cytokinetics, Incorporated (CYTK) has delivered promising news regarding its drug candidate CK-586, a cardiac myosin inhibitor designed to treat a specific subgroup of patients with heart failure with preserved ejection fraction (HFpEF). Data from the Phase 1 study, presented at the American College of Clinical Pharmacology Annual Meeting, demonstrated that CK-586 was safe and well-tolerated in healthy participants.
The study met its primary and secondary objectives, evaluating the safety, tolerability, and pharmacokinetics (PK) of single and multiple oral doses of CK-586. The results indicated that CK-586 exhibited a half-life ranging from 14 to 17 hours, demonstrating dose-linearity without changes in half-life across a wide range of exposures. Steady-state levels were observed within seven days of dosing.
Interestingly, the study also revealed that CK-586 decreased left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) from baseline in an exposure-dependent manner. This finding is significant because LVEF measures how effectively the heart pumps blood, and a decrease suggests a potential beneficial effect of CK-586 on cardiac function. The pharmacokinetic/pharmacodynamic (PK/PD) relationship between CK-586 and these cardiac parameters appeared shallow and predictable.
The study’s findings support the potential for once-daily fixed-dose administration of CK-586, simplifying future treatment regimens. Cytokinetics is currently preparing for a Phase 2 clinical trial in patients with HFpEF, with the trial expected to begin in the fourth quarter of 2024.
The positive data from the Phase 1 study has been well-received by investors, with CYTK stock experiencing a 2.71% increase at last check on Monday. This encouraging development could significantly impact the future of HFpEF treatment, bringing hope to millions of patients suffering from this debilitating condition.
