New phase 2b/3 trial results with MSD's experimental respiratory syncytial virus (RSV) antibody clesrovimab have fired a shot across the bows of AstraZeneca and Sanofi, currently predicting blockbuster sales for rival Beyfortus.In the study, clesrovimab (MK-1654) significantly reduced the incidence of RSV disease and hospitalisations in healthy preterm and full-term infants, putting MSD in a position to potentially file the drug and get approval ahead of the 2025-26 RSV season.The company said clesrovimab could become the first therapy to protect infants with the same single dose, regardless of their weight, for the duration of their first RSV season.

。在这项研究中，clesrovimab（MK-1654）显着降低了健康早产儿和足月婴儿的RSV疾病和住院率，使MSD有可能在2025-26 RSV季节之前提交药物并获得批准。该公司表示，在第一个呼吸道合胞病毒季节期间，克莱斯罗维单抗可能成为第一种保护单剂量婴儿的疗法，无论其体重如何。

It teased the positive results in July.Along with Beyfortus (nirsevimab), it is also a potential rival to Pfizer's RSV vaccine Abrysvo, which can be given to women during pregnancy to protect their babies for the first six months after birth.Globally, RSV infection is a leading cause of hospitalisation for otherwise healthy infants under one year of age.The 3,600-subject MK-1654-004 trial reported at the IDWeek 2024 congress in Los Angeles tested a single dose of clesrovimab given to healthy preterm and full-term infants from birth up to one year of age.The antibody achieved a 60% reduction in the incidence of RSV-associated medically attended lower respiratory infections (RTIs) compared to placebo over five months of follow-up, the trial's primary endpoint, whilst also cutting overall RSV hospitalisations by 84%.Two other secondary endpoints – hospitalisation prompted by RSV lower respiratory infections (LRI) and RSV-associated medically attended lower respiratory infections (MALRI) – were reduced by 91% and 92%, respectively, at the same timepoint.The efficacy stacks up well against Beyfortus, which reduced hospitalisati.

它嘲笑了7月份的积极成果。与Beyfortus（nirsevimab）一起，它也是辉瑞公司RSV疫苗Abrysvo的潜在竞争对手，该疫苗可以在怀孕期间给予女性，以保护她们出生后头六个月的婴儿。在全球范围内，RSV感染是一岁以下其他健康婴儿住院的主要原因。在洛杉矶举行的IDWeek 2024大会上报告的3600名受试者MK-1654-004试验测试了从出生到一岁的健康早产儿和足月婴儿服用单剂量的clesrovimab。在试验的主要终点五个月的随访中，与安慰剂相比，该抗体使RSV相关的医学治疗下呼吸道感染（RTI）的发病率降低了60%，同时也将RSV的总体住院率降低了84%。其他两个次要终点-由RSV下呼吸道感染（LRI）引起的住院治疗和与RSV相关的医学上就诊的下呼吸道感染（MALRI）-在同一时间点分别减少了91%和92%。这种功效与Beyfortus相比表现良好，Beyfortus降低了住院率。