Cytokinetics Sets Stage For Mid-Stage Study For Heart Failure Drug After Encouraging Data From Phase 1 Study
Cytokinetics Sets Stage For Mid-Stage Study For Heart Failure Drug After 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.
週一，Cytokinetics, Incorporated（納斯達克股票代碼：CYTK）宣佈，在馬里蘭州貝塞斯達舉行的美國臨床藥理學會年會的海報發佈會上，公佈了Ck-4021586（Ck-586）1期研究的數據。
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.
該研究實現了其主要和次要目標，即評估單劑量和多劑量口服Ck-586的安全性、耐受性和藥代動力學（PK）。
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.
Ck-586 是一種心肌球蛋白抑制劑，正在開發中，可能用於治療一組伴有過度收縮和心室肥大的症狀 HfpEF 患者。
The study data showed that CK-586 was safe and well tolerated in healthy participants.
研究數據表明，Ck-586在健康參與者中是安全的，耐受性良好。
No serious adverse events were observed, and the stopping criteria for the study were not met.
未觀察到嚴重的不良事件，也未達到該研究的停止標準。
The half-life of CK-586 was observed to be in the range of 14 to 17 hours.
觀測到Ck-586的半衰期在14至17小時之間。
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.
Ck-586在廣泛的暴露範圍內表現出劑量線性度，半衰期沒有變化，在給藥後的七天內出現明顯的穩定狀態。
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.
左心室射血分數（LVEF）和左心室分數縮短（LVFS）以暴露依賴的方式從基線下降，藥代動力學/藥效學（PK/PD）關係顯得淺薄且可預測。
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%.
射血分數衡量心臟的功能狀況。它以百分比表示，表示每次收縮時心臟會抽出多少血液。在最高單劑量爲600 mg時，LVEF的平均降幅小於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.
這些結果顯示了藥理特性，將來可以實現每天一次的固定劑量給藥。一項針對射血分數保持不變（HfpEF）的心力衰竭患者的2期臨床試驗的準備工作正在進行中，該試驗預計將於2024年第四季度開始。
Price Action: CYTK stock is up 2.71% at $55.56 at last check Monday.
價格走勢：週一最後一次檢查時，CyTK股價上漲2.71％，至55.56美元。
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譯文內容由第三人軟體翻譯。