LONDON--(BUSINESS WIRE)--Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the “Company”), a global clinical stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today presented end-of-treatment data from its Phase 2 ALPACAR-360 study of zerlasiran, a short interfering RNA (siRNA), in atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L).

伦敦--（商业新闻短讯）--沉默治疗公司，纳斯达克：SLN（“沉默”或“公司”），一家全球临床阶段的生物技术公司，致力于通过精密工程药物沉默疾病来改变人们的生活，今天提供了其对脂蛋白（a）[Lp（a）]水平高（≥125 nmol/L）的动脉粥样硬化性心血管疾病（ASCVD）患者的Zeralisran（一种短干扰RNA（siRNA））的2期ALPACAR-360研究的治疗结束数据。

These data were presented during the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2024 in Chicago, Illinois, and simultaneously published in the Journal of the American Medical Association (JAMA)..

这些数据是在伊利诺伊州芝加哥举行的2024年美国心脏协会（AHA）科学会议的后期科学会议上提出的，同时发表在《美国医学会杂志》（JAMA）上。。

Results presented today showed that zerlasiran (300 mg every 16 weeks, 300 mg every 24 weeks or 450 mg every 24 weeks) produced greater than 80% mean time-averaged placebo-adjusted reductions from baseline in Lp(a) concentrations over 36 weeks. This is the first study to report time-averaged Lp(a) analyses, which more accurately evaluates the effects of treatment over time, including intervals between doses.

今天公布的结果显示，泽拉西兰（每16周300毫克，每24周300毫克或每24周450毫克）在36周内产生的Lp（a）浓度平均时间平均安慰剂调整后比基线降低80%以上。这是第一项报告时间平均Lp（a）分析的研究，该分析更准确地评估了治疗随时间的影响，包括剂量间隔。

Maximum Lp(a) reductions exceeded 90%. At the final visit, 60 weeks following initial drug administration, reductions in Lp(a) persisted and no safety concerns emerged with infrequent dosing..

最大Lp（a）减少超过90%。在初次给药后60周的最后一次就诊中，Lp（a）的减少持续存在，并且不经常给药也没有出现安全问题。。

“These data provide additional information to select the best dose and dosing interval for future zerlasiran Phase 3 trials,” said Steven E. Nissen, MD, Chief Academic Officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic and the study’s lead author. “Elevated Lp(a) impacts at least 20% of the global population and is a major cause for morbidity and mortality globally.

克利夫兰诊所（Cleveland Clinic）心脏、血管和胸腔研究所（Heart，Vascular and Thoratic Institute）首席学术官、该研究的主要作者史蒂文·尼森（Steven E.Nissen）医学博士说：“这些数据提供了额外的信息，可以为未来的Zeralisran 3期试验选择最佳剂量和给药间隔。”。“Lp（a）升高影响全球至少20%的人口，是全球发病率和死亡率的主要原因。

This is a genetic risk factor that we’ve been unable to treat and I’m excited about the potential for gene-silencing approaches to help these patients.”.

这是一个我们无法治疗的遗传风险因素，我对基因沉默方法帮助这些患者的潜力感到兴奋。”。

“Additional results from the ALPACAR-360 study continue to support the competitive profile of zerlasiran on key clinical endpoints assessing time-averaged reduction, maximum effect and tolerability,” said Curtis Rambaran, MD, Chief Medical Officer at Silence. “The Phase 2 data show zerlasiran has the potential to provide long term reductions in Lp(a) with infrequent dosing.

“ALPACAR-360研究的其他结果继续支持Zeralisran在评估时间平均减少，最大效果和耐受性的关键临床终点上的竞争概况，”沉默首席医疗官柯蒂斯·兰巴兰医学博士说。“第二阶段的数据显示，泽拉西兰有可能在不频繁给药的情况下长期降低Lp（a）。

We look forward to progressing zerlasiran into Phase 3 as a potentially promising new treatment for patients with high Lp(a).”.

我们期待着将zerlasiran进展到第3阶段，作为高Lp（a）患者潜在的有希望的新治疗方法。”。

About Lp(a)

关于Lp（a）

Lp(a) is genetically determined1-5 and a presumed independent risk factor for cardiovascular disease (CVD). Although an agreed-upon threshold for high Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).3,4 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of high Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.5.

Lp（a）是遗传决定的1-5，是心血管疾病（CVD）的独立危险因素。虽然高Lp（a）的商定阈值尚未确定，但大约20%的成年人Lp（a）>125 nmol/L（或约50 mg/dL）[3,4]。病理生理学，流行病学和遗传学研究表明，高Lp（a）在心肌梗死，中风和外周动脉疾病中的潜在作用。

About ALPACAR-360

关于ALPACAR-360

The ALPACAR-360 clinical program was designed to evaluate Silence’s investigational zerlasiran in patients with atherosclerotic cardiovascular disease (ASCVD) and high Lp(a) levels to reduce the risk of cardiovascular events. The ALPACAR-360 trial was a multicenter, randomized, double-blind, placebo-controlled dose-finding Phase 2 study in 178 patients with ASCVD and Lp(a) ≥125 nmol/L.

ALPACAR-360临床计划旨在评估沉默研究Zeralisran在动脉粥样硬化性心血管疾病（ASCVD）和高Lp（a）水平患者中的作用，以降低心血管事件的风险。ALPACAR-360试验是一项多中心，随机，双盲，安慰剂对照剂量发现2期研究，对178例ASCVD和Lp（a）≥125 nmol/L的患者进行研究。

Baseline Lp(a) concentration was 213 nmol/L. Patients were randomly assigned to one of three active subcutaneous doses of zerlasiran (300 mg Q16 weeks, 300 mg Q24 weeks, 450 mg Q24 weeks) or placebo. The primary endpoint was time-averaged change in Lp(a) from baseline to 36 weeks. Secondary endpoints included time-averaged changes in LDL-C as well as time-averaged Lp(a) to 48 weeks (end of treatment period) and 60 weeks (end of study)..

基线Lp（a）浓度为213 nmol/L。患者被随机分配到三种活性皮下剂量的Zeralisran（300 mg Q16周，300 mg Q24周，450 mg Q24周）或安慰剂中的一种。主要终点是Lp（a）从基线到36周的时间平均变化。次要终点包括LDL-C的时间平均变化以及48周（治疗期结束）和60周（研究结束）的时间平均Lp（a）。。

About Silence Therapeutics

关于沉默疗法

Silence Therapeutics is a global clinical stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLD™ platform to create innovative siRNAs designed to precisely target and silence disease associated genes in the liver, which represents a substantial opportunity.

沉默疗法（Silence Therapeutics）是一家全球临床阶段生物技术公司，致力于通过专有siRNA（短干扰RNA）技术创建的精密工程药物沉默疾病，从而改变人们的生活。沉默利用其mRNAi GOLD™平台创建创新的siRNA，旨在精确靶向和沉默肝脏中与疾病相关的基因，这是一个巨大的机会。

Silence focuses on areas of high unmet medical need with programs advancing in cardiovascular disease, hematology and rare diseases. Silence also maintains research and development collaborations with AstraZeneca and Hansoh Pharma, among others. For more information, please visit https://www.silence-therapeutics.com/..

。沉默公司还与阿斯利康和汉索制药等公司保持研发合作。有关更多信息，请访问https://www.silence-therapeutics.com/..

Forward-Looking Statements

前瞻性声明

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words.

本新闻稿包含1995年《私人证券诉讼改革法案》安全港条款所指的“前瞻性声明”。这些陈述可以用“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“计划”、“可能”、“潜在”、“寻求”、“将”等词语以及这些词语的变体或旨在识别前瞻性陈述的类似表达来识别，尽管并非所有前瞻性陈述都包含这些词语。

All statements in this press release, other than statements of historical facts, are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: the Company’s clinical development plans of zerlasiran including selection of the dose and dosing interval and the Company’s timing, plans and potential to move into Phase 3 registrational trial; the Company’s ability to create gene-silencing approaches to help patients with ASCVD and high Lp(a) levels to reduce the risk of cardiovascular events; and the potential clinical benefits and efficacy and safety of zerlasiran.

除历史事实声明外，本新闻稿中的所有声明均为前瞻性声明。本新闻稿中的前瞻性声明包括但不限于以下声明：公司的Zeralisran临床开发计划，包括剂量和给药间隔的选择以及公司进入3期注册试验的时间、计划和潜力；该公司创造基因沉默方法的能力，以帮助ASCVD和高Lp（a）水平的患者降低心血管事件的风险；以及zerlasiran的潜在临床益处，有效性和安全性。

Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control.

任何前瞻性声明都是基于管理层当前对未来事件的期望和信念，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际事件或结果与此类前瞻性声明中规定或暗示的事件或结果产生重大不利影响，其中许多事件或结果超出了公司的控制范围。

These risks and uncertainties include, but are not limited to: the impact of worsening macroeconomic conditions, including the conflict in Ukraine and the conflict between Israel and Hamas, heightened inflation and uncertain credit and financial markets.

这些风险和不确定性包括但不限于：宏观经济状况恶化的影响，包括乌克兰冲突和以色列与哈马斯之间的冲突，通货膨胀加剧以及信贷和金融市场不稳定。

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