GSK plc (LSE/NYSE: GSK) today announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD).

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布了日场（MATINEE）的正面头条结果，日场是一项评估Nucala（mepolizumab）的III期临床试验，Nucala是一种针对慢性阻塞性肺疾病（COPD）成人白细胞介素-5（IL-5）的单克隆抗体。

The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema, who were receiving optimised inhaled maintenance therapy. Participants were also required to have evidence of type 2 inflammation characterised by raised blood eosinophil count.1 MATINEE met its primary endpoint with the addition of Nucala to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks..

该试验招募了患有慢性支气管炎和/或肺气肿的广泛临床表现的COPD患者，他们正在接受优化的吸入维持治疗。参与者还需要有以血液嗜酸性粒细胞计数升高为特征的2型炎症的证据。日场在吸入维持治疗中加入Nucala，达到了其主要终点，研究结果显示，与安慰剂相比，中度/重度急性发作的年化率降低了统计学意义和临床意义，患者治疗长达104周。。

The preliminary safety results are consistent with the known safety profile of Nucala. Further analysis of these data is ongoing.

初步安全结果与努卡拉的已知安全概况一致。对这些数据的进一步分析正在进行中。

COPD affects more than 300 million people globally with up to 40% of patients exhibiting type 2 inflammation characterised by raised blood eosinophil count, that drives exacerbations.3,4 IL-5 is a key messenger protein (cytokine) in type 2 inflammation.5 Recurrent exacerbations lead to damage to the lungs, progressive lung function decline and risk of hospitalisation.

COPD影响全球超过3亿人，高达40%的患者表现出2型炎症，其特征是血液嗜酸性粒细胞计数升高，导致恶化[3,4]。IL-5是2型炎症中的关键信使蛋白（细胞因子）[5]。复发性恶化导致肺部损伤，进行性肺功能下降和住院风险。

This can result in a vicious cycle of deterioration in overall physical health, which leads to worsening of symptoms and quality of life, and increased mortality.6,7.

这可能导致整体身体健康恶化的恶性循环，导致症状和生活质量恶化，死亡率增加[6,7]。

The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities. Nucala is currently not indicated for COPD anywhere in the world.

日场的全部结果将在未来的科学大会上公布，并将为正在与监管机构进行的讨论提供信息。努卡拉目前在世界任何地方都不适用于COPD。

About the mepolizumab development programme for COPD

关于mepolizumab COPD发展计划

The mepolizumab program in COPD is comprised of three clinical trials. The first two studies, METREX and METREO, completed in 2017. MATINEE was designed to supplement METREX and METREO, building on our learnings from these studies and IL-5 science to identify the patients who could benefit the most from Nucala and support future submissions and approvals for use in this indication.3.

COPD中的mepolizumab计划由三项临床试验组成。前两项研究METREX和METREO于2017年完成。日场旨在补充METREX和METREO，以我们从这些研究和IL-5科学中获得的知识为基础，确定哪些患者可以从Nucala中受益最大，并支持未来提交和批准用于该适应症。

MATINEE is a multi-centre, randomised, placebo controlled, double-blind, parallel group study. The trial is designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in 806 COPD participants who were randomised to receive mepolizumab, or a placebo, as an add on to their optimised maintenance COPD therapy for at least 52 weeks and up to a maximum of 104 weeks.1.

日场是一项多中心、随机、安慰剂对照、双盲、平行组研究。该试验旨在证实mepolizumab治疗对806名随机接受mepolizumab或安慰剂的COPD参与者中度或重度恶化的益处，作为其优化维持COPD治疗的补充，至少52周，最多104周。

About Nucala

关于努卡拉

First approved in 2015 for severe asthma with an eosinophilic phenotype in the US, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation..

2015年首次在美国批准用于嗜酸性粒细胞表型的严重哮喘，mepolizumab是一种单克隆抗体，可靶向并结合白细胞介素-5（IL-5），白细胞介素-5是2型炎症中的关键信使蛋白（细胞因子）。。。

For product and important safety information please consult the country relevant summary of product characteristics. EU and UK available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf

有关产品和重要安全信息，请参阅国家相关产品特性摘要。欧盟和英国网址：https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf

About chronic obstructive pulmonary disease (COPD)

关于慢性阻塞性肺疾病（COPD）

COPD is the third leading cause of death worldwide with exacerbations accounting for the greatest proportion of the total COPD burden on the healthcare system.2 Patients with COPD have chronic inflammation leading to persistent respiratory symptoms such as breathlessness and a productive cough. The daily impact on patients’ lives can lead to anxiety and depression.6 Exacerbations are acute episodes of worsening COPD symptoms and can result in hospitalisation, irreversible and cumulative lung damage or death.6 Many patients continue to experience exacerbations despite standard treatment meaning that there is a need for targeted therapies that address the underlying pathobiology.6,10,11 Up to 40% of patients have evidence of type 2 inflammation that drives exacerbations.3,4 Blood eosinophil count is a biomarker for type 2 inflammation that can be easily measured by a simple blood test and indicates a patient’s risk of exacerbation and deterioration, and response to treatment in COPD.6 IL-5 is a core cytokine in type 2 inflammation.

COPD是全球第三大死亡原因，恶化占医疗系统COPD总负担的最大比例。2 COPD患者患有慢性炎症，导致持续的呼吸道症状，如呼吸困难和咳嗽。对患者生活的日常影响可能导致焦虑和抑郁[6]。急性加重是COPD症状恶化的急性发作，可导致住院，不可逆转和累积的肺损伤或死亡[6]。尽管标准治疗意味着需要针对潜在病理生物学的靶向治疗，但许多患者仍会继续恶化[6,10,11]。高达40%的患者有2型炎症的证据，可导致恶化[3,4]。血液嗜酸性粒细胞计数是2型炎症的生物标志物，可以通过简单的血液检测轻松测量，并指示患者恶化和恶化的风险，以及对COPD治疗的反应[6]。5是2型炎症的核心细胞因子。

It is a major protein responsible for the growth, maturation, activation and survival of eosinophils, a type of white blood cell implicated in the pathogenesis of type 2 inflammatory diseases. Evidence indicates that IL-5 has an impact on other cell types beyond eosinophils, including those that contribute to inflammation, lung remodelling and disease progression.12-16.

它是负责嗜酸性粒细胞生长，成熟，活化和存活的主要蛋白质，嗜酸性粒细胞是一种白细胞，与2型炎症性疾病的发病机制有关。有证据表明，IL-5对嗜酸性粒细胞以外的其他细胞类型有影响，包括那些导致炎症，肺重塑和疾病进展的细胞。

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。