LONDON--(BUSINESS WIRE)--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 positive topline results from the multiple dose component of the APOLLO phase 1 study of zerlasiran (formerly SLN360) in 36 adults with baseline lipoprotein(a), or Lp(a), levels at or over 150 nmol/L and stable atherosclerotic cardiovascular disease (ASCVD).

LONDON-（BUSINESS WIRE）-纳斯达克股票代码Silence Therapeutics plc:SLN（“Silence”或“Company”）是一家经验丰富且创新的生物技术公司，致力于通过精密工程药物沉默疾病来改变人们的生活，今天宣布，在36名基线脂蛋白（a）或Lp（a）水平达到或超过150 nmol/L且稳定的动脉粥样硬化的成年人中，zerlasiran（以前称为SLN360）的APOLLO 1期研究的多剂量组分的阳性结果心血管疾病（ASCVD）。

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 approximately 20% of the world’s population..

Zerlasiran是一种siRNA（短干扰RNA），旨在降低人体Lp（a）的产生，Lp（a）是影响全球约20%人口的心血管疾病的关键遗传危险因素。。

In the double-blind placebo-controlled treatment period, zerlasiran (200 mg, 300 mg and 450 mg) was administered twice subcutaneously at two different dosing intervals to ASCVD patients. These data demonstrated a significant reduction from baseline in Lp(a) of up to 99% at 90 days following injection of repeated doses.

在双盲安慰剂对照治疗期间，将zerlasiran（200mg，300mg和450mg）以两种不同的给药间隔皮下给予ASCVD患者两次。这些数据表明，在注射重复剂量后90天，Lp（a）从基线显着降低高达99%。

Lp(a) levels remained approximately 90% lower than baseline at 201 days (end of treatment period) at the two highest doses. A dose dependent reduction in low-density lipoprotein cholesterol (LDL cholesterol) and apolipoprotein B (ApoB) was also observed. Zerlasiran was well tolerated; no clinically important safety concerns were identified..

在两个最高剂量的201天（治疗结束期），Lp（a）水平仍然比基线低约90%。还观察到低密度脂蛋白胆固醇（LDL胆固醇）和载脂蛋白B（ApoB）的剂量依赖性降低。Zerlasiran耐受性良好；没有发现临床上重要的安全问题。。

“We are extremely pleased to see the excellent results we saw in healthy volunteers translate to our target population,” said Craig Tooman, President and CEO of Silence. “Zerlasiran delivered essentially complete Lp(a) knockdown on repeated dosing with greater durability than seen with single doses.

“我们非常高兴地看到我们在健康志愿者中看到的优异成果转化为我们的目标人群，”Silence总裁兼首席执行官Craig Tooman说。“Zerlasiran在重复给药时基本上完成了Lp（a）的击倒，其耐久性比单剂量更高。

The safety profile also continues to be very well suited for chronic use in a very large global population. We look forward to building on this dataset with the ongoing phase 2 study expected to readout in the first half of next year.”.

安全概况也继续非常适合在非常庞大的全球人口中长期使用。我们期待在这个数据集的基础上进行正在进行的第二阶段研究，预计将在明年上半年读出“。

Silence plans to present further results from the APOLLO multiple dose study at a future cardiovascular medicines conference.

Silence计划在未来的心血管药物会议上展示APOLLO多剂量研究的进一步结果。

Results from the single ascending dose portion of the APOLLO study were simultaneously presented in a late breaker at the 2022 American College of Cardiology (ACC) Annual Meeting and published in the Journal of the American Medical Association (JAMA), available here.

阿波罗研究的单次递增剂量部分的结果同时在2022年美国心脏病学会（ACC）年会上以较晚的突破形式呈现，并发表在美国医学会（JAMA）杂志上，可在此处获得。

Zerlasiran is currently being evaluated in the fully enrolled ALPACAR-360 phase 2 study in patients with Lp(a) levels at or over 125 nmol/L at high risk of ASCVD events. Silence expects to report topline 36-week data in the first quarter of 2024 and topline 48-week data in the second quarter of 2024..

Zerlasiran目前正在完全登记的ALPACAR-360 2期研究中对Lp（a）水平在125 nmol/L或以上且ASCVD事件高风险的患者进行评估。Silence预计将在2024年第一季度报告topline 36周数据，在2024年第二季度报告topline 48周数据。。

About Silence Therapeutics

关于沉默疗法

Silence Therapeutics is developing a new generation of medicines by harnessing the body's natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet need. Silence's proprietary mRNAi GOLD™ platform can be used to create siRNAs (short interfering RNAs) that precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity.

沉默疗法正在利用人体RNA干扰的自然机制或RNAi来开发新一代药物，以抑制被认为在具有显着未满足需求的疾病的病理学中起作用的特定靶基因的表达。Silence专有的mRNAi黄金™ 平台可用于创建siRNA（短干扰RNA），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's wholly owned product candidates include zerlasiran designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of lipoprotein(a) and SLN124 designed to address hematological diseases. Silence also maintains ongoing research and development collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals, and Hansoh Pharma, among others.

Silence的合资产品候选人包括zerlasiran，旨在解决高水平脂蛋白（a）和SLN124旨在解决血液疾病的人降低心血管风险的高度和普遍未满足的医疗需求。Silence还与AstraZeneca，Mallinckrodt Pharmaceuticals和Hansoh Pharma等公司保持持续的研发合作。

For more information, please visit https://www.silence-therapeutics.com/..

欲了解更多信息，请访问https://www.silence-therapeutics.com/..

Forward-Looking Statements

前瞻性声明

Certain statements made in this announcement are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other securities laws, including with respect to the Company’s cash runway and forecast operating cash flow, the Company’s clinical and commercial prospects, regulatory approvals of the Company’s product candidates, potential partnerships or collaborations or payments under new and existing collaborations, the initiation or completion of the Company’s clinical trials and the anticipated timing or outcomes of data reports from the Company’s clinical trials.

本公告中所作的某些陈述是1995年“美国私人证券诉讼改革法”及其他证券法（包括公司现金跑道和预测经营现金流量，公司临床和商业前景，公司产品候选人的监管批准，新合作和现有合作下的潜在合作伙伴关系或合作或支付，公司临床试验的启动或完成以及公司临床试验数据报告的预期时间或结果。

These forward-looking statements are not historical facts but rather are based on the Company's current assumptions, beliefs, expectations, estimates and projections about its industry. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” and similar expressions are intended to identify forward-looking statements.

这些前瞻性陈述不是历史事实，而是基于公司目前对其行业的假设，信念，期望，估计和预测。诸如“预期”，“期望”，“打算”，“计划”，“相信”，“寻求”，“估计”之类的词语旨在识别前瞻性陈述。

These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including those risks identified in the Company’s most recent Admission Document and its Annual Report on Form 20-F filed with the U.S.

这些陈述不能保证未来的业绩，并受到已知和未知的风险，不确定性和其他因素的影响，其中一些因素超出公司的控制范围，难以预测，并可能导致实际结果与表达或预测的结果大不相同。在前瞻性陈述中，包括本公司最新录取文件及其提交给美国的表格20-F年度报告中确定的风险。

Securities and Exchange Commission on March 15, 2023. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the da.

2023年3月15日证券交易所。本公司警告担保人和潜在担保人不要过分依赖这些前瞻性声明，这些声明仅在本公告发布之日起反映本公司的观点。本公告中提出的前瞻性声明仅涉及截至da的事件。