Silence Therapeutics Announces JAMA Publication Of Additional APOLLO Phase 1 Data For Zerlasiran In Subjects With Elevated Lipoprotein(a)
Silence Therapeutics Announces JAMA Publication Of Additional APOLLO Phase 1 Data For Zerlasiran In Subjects With Elevated Lipoprotein(a)
Silence Therapeutics plc, Nasdaq: SLN ("Silence" or the "Company"), an experienced and innovative biotechnology company committed to transforming people's lives by silencing diseases through precision engineered medicines, today announced additional results from the APOLLO phase 1 study of zerlasiran (SLN360) in subjects with baseline lipoprotein(a), or Lp(a), levels at or over 150 nmol/L were published in the Journal of the American Medical Association (JAMA), linked here.
Silence Therapeutics plc，納斯達克：SLN（“Silence” 或 “公司”）是一家經驗豐富、創新的生物技術公司，致力於通過精密工程藥物消滅疾病來改變人們的生活。該公司今天宣佈了對基線脂蛋白（a）或Lp（a）水平等於或超過150 nmol/L的受試者進行的阿波羅1期研究的更多結果 SLN360 美國醫學會雜誌 (JAMA)，鏈接在這裏。
Zerlasiran is a siRNA (short interfering RNA) designed to lower the body's production of Lp(a), a key genetic risk factor for cardiovascular disease affecting up to 20% of the world's population.
Zerlasiran是一種siRNA（短干擾RNA），旨在降低人體產生Lp（a），Lp（a）是影響全球多達20％人口的心血管疾病的關鍵遺傳危險因素。
"Positive phase 1 data published in JAMA demonstrate treatment with zerlasiran produced sustained reductions in Lp(a) concentrations with a well-tolerated profile using varying dosing regimens," said Curtis Rambaran, MD, Chief Medical Officer at Silence and senior author of the publication. "The promising findings from this study are particularly encouraging as we complete the phase 2 study for zerlasiran and underscore our commitment to address this major unmet need in cardiovascular disease."
Silence首席醫學官、該出版物的資深作者柯蒂斯·蘭巴蘭醫學博士說：“在JAMA上公佈的1期陽性數據表明，使用zerlasiran進行治療後，Lp（a）濃度持續降低，耐受性良好。”“在我們完成zerlasiran的2期研究時，這項研究的令人鼓舞的發現尤其令人鼓舞，這也凸顯了我們對解決心血管疾病這一主要未滿足需求的承諾。”
The single ascending and multiple dose trial enrolled 32 healthy participants and 36 patients with atherosclerotic cardiovascular disease (ASCVD) and Lp(a) concentrations ≥150 nmol/L. Results from the single ascending dose portion of the trial in healthy participants were previously published in the April 2022 issue of JAMA, linked here. Today's JAMA publication reviews findings from the extended 365 day follow up of healthy participants who received the two highest zerlasiran doses (300 or 600 mg) and 201 days of follow up for ASCVD patients administered 2 doses.
這項單一上升和多劑量試驗招收了32名健康參與者和36名動脈粥樣硬化性心血管疾病（ASCVD）和Lp（a）濃度≥150 nmol/L的患者。該試驗對健康參與者的單次遞增劑量部分的結果先前發表在2022年4月號的《JAMA》上，鏈接在這裏。今天的JAMA出版物回顧了對接受最高兩劑澤拉西蘭劑量（300或600毫克）的健康參與者延長365天的隨訪結果，對服用2劑的ASCVD患者進行了201天的隨訪。
Healthy participants were randomized and received a single subcutaneous dose of placebo, 300 mg or 600 mg; ASCVD patients received two doses of placebo, 200 mg at a 4-week interval or 300 mg or 450 mg at an 8-week interval. The primary outcome was safety and tolerability. Secondary outcomes included the serum levels of zerlasiran and effects on Lp(a) serum concentrations.
健康參與者被隨機分組，接受單劑量皮下安慰劑，300毫克或600毫克；ASCVD患者接受兩劑安慰劑，間隔4周爲200毫克，間隔8周爲300毫克或450毫克。主要結果是安全性和耐受性。次要結局包括血清中zerlasiran水平和對Lp（a）血清濃度的影響。
Zerlasiran was safe and well tolerated. The median change from baseline in serum Lp(a) concentrations 365 days after single doses for placebo, 300 mg, and 600 mg were +14%, −30%, and −29% respectively. The maximal median change from baseline after two doses of placebo, 200 mg, 300 mg and 450 mg were +7%, -97%, -98% and -99%, attenuating to 0.3%, -60%, 90% and 89% respectively, after 201 days.
Zerlasiran 是安全的，耐受性良好。單劑量安慰劑300 mg和600 mg後365天血清Lp（a）濃度與基線相比的中位數變化分別爲+14％、−30％和−29％。服用兩劑安慰劑（200 mg、300 mg和450 mg）後，與基線相比的最大中位數變化爲+7％、-97％、-98％和-99％，201天后分別減弱至0.3％、-60％、90％和89％。
Zerlasiran is currently being evaluated in the ALPACAR-360 phase 2 study in subjects with baseline Lp(a) levels at or over 125 nmol/L at high risk of ASCVD events.
Zerlasiran 目前正在對基線 Lp (a) 水平等於或超過 125 nmol/L 的受試者進行評估，該研究的受試者有 ASCVD 事件的高風險。ALPACAR-360
譯文內容由第三人軟體翻譯。