首頁(yè) 資訊 默沙東公布抗RSV單抗clesrovimab的2b/3期臨床試驗(yàn)積極結(jié)果

默沙東公布抗RSV單抗clesrovimab的2b/3期臨床試驗(yàn)積極結(jié)果

來(lái)源:泰然健康網(wǎng) 時(shí)間:2024年12月03日 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.

新澤西州拉赫韋(商業(yè)新聞短訊)--默克(紐約證券交易所代碼:MRK),在美國(guó)和加拿大以外被稱為MSD,今天宣布其2b/3期臨床試驗(yàn)(MK-1654-004)的陽(yáng)性結(jié)果,該試驗(yàn)評(píng)估了clesrovimab(MK-1654),該公司的研究性預(yù)防性單克隆抗體旨在保護(hù)嬰兒免受呼吸道合胞病毒(RSV)疾病的影響。

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..

在該試驗(yàn)中,clesrovimab達(dá)到了其主要安全性和有效性終點(diǎn),包括在第150天減少由RSV引起的醫(yī)療護(hù)理下呼吸道感染(MALRI)。這項(xiàng)研究的詳細(xì)結(jié)果將在即將舉行的科學(xué)大會(huì)上公布,默克公司計(jì)劃將這些數(shù)據(jù)提交給全球監(jiān)管機(jī)構(gòu)。。

“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.

默克研究實(shí)驗(yàn)室(Merck Research Laboratories)全球臨床開發(fā)部傳染病和疫苗高級(jí)副總裁Paula Annunziato博士表示:“呼吸道合胞病毒(RSV)具有高度傳染性,可引起嬰兒氣道炎癥,導(dǎo)致呼吸困難。RSV是全球范圍內(nèi)的一種普遍疾病,是健康嬰兒住院的主要原因?!薄?/p>

“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.'.

“我們對(duì)這些發(fā)現(xiàn)感到鼓舞,并期待與監(jiān)管機(jī)構(gòu)合作,提供一種新的選擇,幫助解決RSV對(duì)嬰兒及其家人的影響?!薄?/p>

About MK-1654-004

關(guān)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)是一項(xiàng)2b/3期雙盲,隨機(jī),安慰劑對(duì)照研究,旨在評(píng)估clesrovimab在健康早產(chǎn)兒和足月嬰兒中的安全性和有效性。參與者被隨機(jī)分配接受單劑量的clesrovimab或安慰劑。主要終點(diǎn)包括與安慰劑和安全性相比,從第1天(給藥后)到第150天,與RSV相關(guān)的醫(yī)學(xué)治療下呼吸道感染(MALRI)參與者的發(fā)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)..

評(píng)估的安全措施包括任何注射相關(guān)不良事件(AE),特別感興趣的AE(AESI)引發(fā)全身性AE或嚴(yán)重不良事件(SAE)的參與者百分比。。

About Clesrovimab (MK-1654)

關(guān)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)是一種研究性延長(zhǎng)半衰期單克隆抗體(mAb),作為被動(dòng)免疫而開發(fā),用于預(yù)防RSV相關(guān)的醫(yī)學(xué)治療下呼吸道感染(MALRI)。Clesrovimab正在嬰兒(早產(chǎn)兒和足月)中進(jìn)行研究,以通過(guò)單次固定劑量給藥在其第一個(gè)RSV季節(jié)提供快速,持久的保護(hù)。。

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)是一種傳染性病毒,可引起廣泛的季節(jié)性感染,給嬰兒和老年人帶來(lái)全球負(fù)擔(dān)。健康和高危嬰兒對(duì)預(yù)防選擇的需求都很高。在全球范圍內(nèi),它是一歲以下健康嬰兒住院的主要原因。

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

呼吸道合胞病毒可導(dǎo)致嚴(yán)重的呼吸道疾病,如毛細(xì)支氣管炎和肺炎,估計(jì)全世界每年有101000名5歲以下兒童死亡。。

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.

在美國(guó)和加拿大以外被稱為MSD的默克公司,我們的目標(biāo)是團(tuán)結(jié)一致的:我們利用尖端科學(xué)的力量來(lái)拯救和改善世界各地的生活。130多年來(lái),我們通過(guò)開發(fā)重要的藥物和疫苗給人類帶來(lái)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.

我們立志成為世界上領(lǐng)先的研究密集型生物制藥公司,今天,我們處于研究的前沿,以提供創(chuàng)新的健康解決方案,促進(jìn)人類和動(dòng)物疾病的預(yù)防和治療。我們培養(yǎng)了一支多元化和包容性的全球勞動(dòng)力隊(duì)伍,并每天負(fù)責(zé)任地運(yùn)作,為所有人和社區(qū)創(chuàng)造一個(gè)安全、可持續(xù)和健康的未來(lái)。

相關(guān)知識(shí)

成都無(wú)III期臨床試驗(yàn)
阿斯利康注射新藥RSV抗體在中國(guó)申報(bào)上市,一針能保護(hù)一季
創(chuàng)新高血壓藥3期試驗(yàn)積極結(jié)果公布,已遞交上市申請(qǐng)
RSV新藥井噴:FDA批準(zhǔn)長(zhǎng)效抗體,有望為嬰兒防護(hù)威脅最大的呼吸道病毒
輝瑞、禮來(lái)、強(qiáng)生多家藥企公布炎癥性腸病臨床試驗(yàn)結(jié)果
恒瑞醫(yī)藥首個(gè)全球臨床三期成功 卡瑞利珠單抗對(duì)肝細(xì)胞癌治療有何意義
樂(lè)唯初?在華獲批用于預(yù)防嬰兒呼吸道合胞病毒感染
默沙東宣布:K藥治療前列腺癌和非小細(xì)胞肺癌研究失敗
重癥肌無(wú)力臨床研究獲積極成果,榮昌生物公布新藥泰它西普
13款新藥在中國(guó)獲批上市 拜耳、默沙東、君實(shí)生物均有新藥問(wèn)世

網(wǎng)址: 默沙東公布抗RSV單抗clesrovimab的2b/3期臨床試驗(yàn)積極結(jié)果 http://m.u1s5d6.cn/newsview242957.html

推薦資訊