首页 > 资讯 > 默沙东公布抗RSV单抗clesrovimab的2b/3期临床试验积极结果

默沙东公布抗RSV单抗clesrovimab的2b/3期临床试验积极结果

泰然健康网
2024-12-03 19:23

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.

新泽西州拉赫韦（商业新闻短讯）--默克（纽约证券交易所代码：MRK），在美国和加拿大以外被称为MSD，今天宣布其2b/3期临床试验（MK-1654-004）的阳性结果，该试验评估了clesrovimab（MK-1654），该公司的研究性预防性单克隆抗体旨在保护婴儿免受呼吸道合胞病毒（RSV）疾病的影响。

In the trial, clesrovimab met its primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Detailed findings of the study will be presented at an upcoming scientific congress and Merck plans to file these data with global regulatory authorities..

在该试验中，clesrovimab达到了其主要安全性和有效性终点，包括在第150天减少由RSV引起的医疗护理下呼吸道感染（MALRI）。这项研究的详细结果将在即将举行的科学大会上公布，默克公司计划将这些数据提交给全球监管机构。。

“RSV is highly contagious and can cause inflammation in the airways of infants leading to difficulty breathing. As a widespread illness globally, RSV is the leading cause of hospitalization for healthy infants,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories.

默克研究实验室（Merck Research Laboratories）全球临床开发部传染病和疫苗高级副总裁Paula Annunziato博士表示：“呼吸道合胞病毒（RSV）具有高度传染性，可引起婴儿气道炎症，导致呼吸困难。RSV是全球范围内的一种普遍疾病，是健康婴儿住院的主要原因。”。

“We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families.'.

“我们对这些发现感到鼓舞，并期待与监管机构合作，提供一种新的选择，帮助解决RSV对婴儿及其家人的影响。”。

About MK-1654-004

关于MK-1654-004

MK-1654-004 (NCT04767373) is a Phase 2b/3 double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of clesrovimab in healthy preterm and full-term infants. Participants were randomized to receive either a single dose of clesrovimab or placebo. The primary endpoints include the incidence of participants with RSV-associated medically attended lower respiratory infection (MALRI) from Day 1 (post dose) to Day 150 as compared to placebo and safety.

MK-1654-004（NCT04767373）是一项2b/3期双盲，随机，安慰剂对照研究，旨在评估clesrovimab在健康早产儿和足月婴儿中的安全性和有效性。参与者被随机分配接受单剂量的clesrovimab或安慰剂。主要终点包括与安慰剂和安全性相比，从第1天（给药后）到第150天，与RSV相关的医学治疗下呼吸道感染（MALRI）参与者的发病率。

Safety measures assessed included the percentage of participants with any injection-related adverse events (AEs), AEs of special interest (AESIs) solicited systemic AEs, or serious adverse events (SAEs)..

评估的安全措施包括任何注射相关不良事件（AE），特别感兴趣的AE（AESI）引发全身性AE或严重不良事件（SAE）的参与者百分比。。

About Clesrovimab (MK-1654)

关于Clesrovimab（MK-1654）

Clesrovimab (MK-1654) is an investigational extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV-associated medically attended lower respiratory infection (MALRI). Clesrovimab is being studied in infants (pre-term and full-term) to provide rapid, durable protection through their first RSV season with a single, fixed-dose administration..

Clesrovimab（MK-1654）是一种研究性延长半衰期单克隆抗体（mAb），作为被动免疫而开发，用于预防RSV相关的医学治疗下呼吸道感染（MALRI）。Clesrovimab正在婴儿（早产儿和足月）中进行研究，以通过单次固定剂量给药在其第一个RSV季节提供快速，持久的保护。。

Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infection with a worldwide burden in infants and older adults. There is high unmet need for preventative options in both healthy and high-risk infants. Globally, it is the leading cause of hospitalization for healthy infants under a year old.

呼吸道合胞病毒（RSV）是一种传染性病毒，可引起广泛的季节性感染，给婴儿和老年人带来全球负担。健康和高危婴儿对预防选择的需求都很高。在全球范围内，它是一岁以下健康婴儿住院的主要原因。

RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 101,000 deaths a year worldwide in children under five..

呼吸道合胞病毒可导致严重的呼吸道疾病，如毛细支气管炎和肺炎，估计全世界每年有101000名5岁以下儿童死亡。。

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在美国和加拿大以外被称为MSD的默克公司，我们的目标是团结一致的：我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来，我们通过开发重要的药物和疫苗给人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为世界上领先的研究密集型生物制药公司，今天，我们处于研究的前沿，以提供创新的健康解决方案，促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍，并每天负责任地运作，为所有人和社区创造一个安全、可持续和健康的未来。