GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by blood eosinophil count.1,2  Both SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in the annualised rate of clinically significant exacerbations (asthma attacks) over 52 weeks.1,2 Across both trials the overall incidence and severity of treatment-emergent adverse events were similar in patients treated with either depemokimab or placebo.

GSK plc（伦敦证交所/纽约证交所：GSK）今天宣布了III期临床试验SWIFT-1和SWIFT-2的正面标题结果，该试验评估了依莫单抗与安慰剂在成人和青少年严重哮喘患者中的疗效和安全性，其中2型炎症以血嗜酸性粒细胞计数为特征[1,2]。SWIFT-1和SWIFT-2均达到了其主要终点，即52周内临床显着恶化（哮喘发作）的年化率降低[1,2]。在这两项试验中，依莫单抗或安慰剂治疗的患者出现治疗紧急不良事件的总发生率和严重程度相似。

Further analysis of these data is ongoing..

这些数据的进一步分析正在进行中。。

Depemokimab is the first ultra-long-acting biologic to be evaluated in phase III trials with a binding affinity and high potency for interleukin-5 (IL-5), enabling six-month dosing intervals for patients with severe asthma.1,2,3 IL-5 is known to be a key cytokine (protein) in type 2 inflammation.4,5 This inflammation, typically identified by elevated blood eosinophil count, is the underlying pathology responsible for more than 80% of people with severe asthma and can lead to unpredictable exacerbations.5,6   .

Depemokimab是第一个在III期临床试验中评估的超长效生物制剂，对白细胞介素-5（IL-5）具有结合亲和力和高效力，为严重哮喘患者提供了六个月的给药间隔[1,2,3]。已知IL-5是2型炎症中的关键细胞因子（蛋白质）[4,5]。这种炎症通常由血液嗜酸性粒细胞计数升高所确定，是80%以上严重哮喘患者的潜在病理学，可能导致不可预测的恶化[5,6]。

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said: “These results add to the established body of evidence that targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that drives severe asthma exacerbations. Depemokimab could offer the possibility of sustained inhibition of this pathway, with a dosing schedule of just two injections per year.

呼吸/免疫学研发全球负责人高级副总裁Kaivan Khavandi说：“这些结果进一步证明，靶向抑制IL-5在减少导致严重哮喘恶化的2型炎症中起着关键作用。Depemokimab可以提供持续抑制这一途径的可能性，每年只需注射两次。

This is important as research shows that 73% of physicians7 believe longer dosing intervals would be beneficial to patients who are often juggling multiple therapies.”.

这一点很重要，因为研究表明，73%的医生7认为更长的给药间隔对经常进行多种治疗的患者有益。”。

Expertise in respiratory diseases and the science of IL-5 has informed the ongoing evidence generation program evaluating the impact of six-month dosing of sustained IL-5 inhibition in patients achieving clinical remission in severe asthma.5 The full results of SWIFT-1 and SWIFT-2 will be presented at an upcoming scientific congress and will be used to support regulatory submissions to health authorities worldwide..

呼吸系统疾病和IL-5科学方面的专业知识为正在进行的证据生成计划提供了信息，该计划评估了六个月持续IL-5抑制剂量对重症哮喘临床缓解患者的影响。SWIFT-1和SWIFT-2的全部结果将在即将举行的科学大会上提交，并将用于支持向全球卫生当局提交的监管报告。。

Depemokimab is currently not approved anywhere in the world.

Depemokimab目前尚未在世界任何地方获得批准。

About the depemokimab development programme

关于depemokimab开发计划

The phase III programme consists of SWIFT-1 and SWIFT-2 in severe asthma, along with an open label extension study (AGILE).1,2,8 SWIFT-1 and SWIFT-2 were replicate 52-week, randomised, double-blind, placebo-controlled, parallel-group, multi-centre phase III clinical trials.1,2 The trials assessed the efficacy and safety of depemokimab adjunctive therapy in 375 and 380 participants who were randomised to receive depemokimab or a placebo, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller.1,2 .

III期计划由严重哮喘的SWIFT-1和SWIFT-2以及开放标签扩展研究（AGILE）组成[1,2,8]。SWIFT-1和SWIFT-2重复52周，随机，双盲，安慰剂对照，平行组，多中心III期临床试验[1,2]。该试验评估了375名和380名随机接受depmokimab或安慰剂的参与者的depmokimab辅助治疗的有效性和安全性，以及中高剂量吸入皮质类固醇加上至少一名额外控制者的标准治疗[1,2]。

An additional study (NIMBLE) is underway to assess the efficacy and safety of depemokimab when participants with severe asthma are switched from mepolizumab or benralizumab.9

另一项研究（NIMBLE）正在进行中，以评估严重哮喘患者从mepolizumab或benralizumab转换为depemokimab的疗效和安全性

Depemokimab’s extended half-life has the potential to provide sustained inhibition of broad inflammatory functions and is being investigated in a variety of type 2 inflammatory conditions.1,2,8-13 Depemokimab is also currently being evaluated in phase III trials across a range of other IL-5 mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps (CRSwNP) and hypereosinophilic syndrome (HES).9-12  .

Depemokimab延长的半衰期有可能持续抑制广泛的炎症功能，目前正在各种2型炎症状态下进行研究[1,2,8-13]。Depemokimab目前也正在III期临床试验中评估其他一系列IL-5介导的疾病，包括嗜酸性粒细胞肉芽肿伴多血管炎（EGPA），慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）和嗜酸性粒细胞增多综合征（HES）[9-12]。

About severe asthma and type 2 inflammation

关于严重哮喘和2型炎症

Severe asthma is defined as asthma that requires treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids) or biologic therapy, to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite therapy.5,14 In more than 80% of patients with severe asthma, their condition is driven by type 2 inflammation in which patients exhibit elevated levels of eosinophils (a type of white blood cell).5,6 Blood eosinophils count can be measured via a simple blood test.

严重哮喘被定义为需要用高剂量吸入性皮质类固醇加上第二种控制剂（和/或全身性皮质类固醇）或生物疗法治疗的哮喘，以防止其变得“不受控制”或尽管治疗仍然“不受控制”[5,14]。在超过80%的严重哮喘患者中，他们的病情是由2型炎症驱动的，其中患者表现出嗜酸性粒细胞（一种白细胞）水平升高[5,6]。血液嗜酸性粒细胞计数可以通过简单的血液测试来测量。

IL-5 is a core cytokine (protein) in type 2 inflammation alongside IL-4 and IL-13.5 Type 2 inflammation drives the underlying pathology in a variety of immune-mediated conditions. IL-5 is responsible for the growth, activity and survival of eosinophils.5  .

IL-5是2型炎症中的核心细胞因子（蛋白质），与IL-4和IL-13.5一起。2型炎症在各种免疫介导的病症中驱动潜在的病理学。IL-5负责嗜酸性粒细胞的生长，活性和存活。

About GSK in respiratory

关于呼吸系统中的GSK

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease.

葛兰素史克公司继续在数十年开创性工作的基础上，为数亿呼吸系统疾病患者提供更具雄心的治疗目标，制定下一代护理标准，并重新定义呼吸医学的未来。凭借业界领先的呼吸产品组合和疫苗、靶向生物制剂和吸入药物管道，我们专注于改善患有各种类型哮喘和COPD以及不太了解的难治性慢性咳嗽或罕见疾病（如系统性硬化症伴间质性肺病）的患者的预后和生活。

GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression..

葛兰素史克利用最新的科学技术，旨在改变潜在的疾病功能障碍，预防疾病进展。。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。