GSK's Asthma Drug Meets Main Goal In Phase 3 Study In Patients With Smoker's Lungs, Prepares Competition With Amgen/AstraZeneca's Drug
GSK's Asthma Drug Meets Main Goal In Phase 3 Study In Patients With Smoker's Lungs, Prepares Competition With Amgen/AstraZeneca's Drug
Participants were also required to have evidence of type 2 inflammation characterized by raised blood eosinophil count.Friday, GSK plc (NYSE:GSK) released the headline results of the MATINEE Phase 3 trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD), or smoker's lungs.
周五，格兰史密斯克莱恩有限公司（纽交所：GSK）发布了MATINEE第三期临床试验的头条结果，评估了Nucala（美妥拉珠单抗）在慢性阻塞性肺疾病（COPD）或吸烟者肺中靶向白细胞介素-5（IL-5）的疗效。
The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema who were receiving optimized inhaled maintenance therapy.
该试验招募了慢性支气管炎和/或肺气肿具有广泛临床表现的COPD患者，这些患者正在接受优化的吸入维持治疗。
Also Read: Amgen/AstraZeneca Say Asthma Drug Shows Activity In Another Lung Disease Across Broad Patient Population.
此外阅读：安进/阿斯利康表示喘息药物在广泛的患者群体中对另一种肺部疾病表现出活性。
Participants were also required to have evidence of type 2 inflammation characterized by raised blood eosinophil count.
参与者还需要有第2型炎症的证据，其特点是血液嗜酸性粒细胞计数增高。
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 annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.
MATINEE通过加用Nucala到吸入维持治疗中，达到了主要终点，并且研究结果显示，与安慰剂相比，治疗104周的患者中，中/重度加重的年化发生率有统计学意义和临床意义的降低。
The preliminary safety results are consistent with the known safety profile of Nucala. Further analysis of these data is ongoing.
初步的安全性结果与Nucala已知的安全性概况一致。进一步分析这些数据正在进行中。
COPD affects more than 300 million people globally, with up to 40% of patients exhibiting type 2 inflammation characterized by raised blood eosinophil count, which drives exacerbations.
COPD在全球范围内影响3亿多人，其中最多40%的患者出现血液嗜酸性粒细胞计数增高的第2型炎症，这导致加重。
The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities.
MATINEE的全部结果将在将来的科学大会上公布，并将用于与监管机构的持续讨论。
Nucala is already approved as an add-on, prescription maintenance treatment for patients six and older with severe eosinophilic asthma.
Nucala已经获得批准，作为附加的处方维持治疗，用于六岁及以上患有严重嗜酸性哮喘的患者。
Nucala is currently not indicated for COPD anywhere in the world.
Nucala目前在全球范围内没有用于COPD的适应症。
The drug contributed 6% to GSK's 2023 sales, with revenue of 1.65 billion pounds, up 18% at CER year over year.
该药物对GSK的2023年销售额贡献了6%，营业收入为16.5亿英镑，同比按恒定汇率计算增长了18%。
In June, the FDA approved Verona Pharma plc's (NASDAQ:VRNA) Ohtuvayre (ensifentrine) for the maintenance treatment of COPD in adult patients.
今年6月，FDA批准了维罗纳制药股份有限公司（NASDAQ：VRNA）的Ohtuvayre（ensifentrine）用于成年患者COPD的维持治疗。
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
奥托维亚雷是一种具有新机制作用的吸入性产品，用于COPD的维持治疗，已有20多年时间没有出现过。
Price Action: GSK stock is up 0.86% at $43.50 during the premarket session at last check Friday.
股票价格行动：GSK股票在周五的盘前交易中上涨了0.86%，至43.50美元。
Photo via Shutterstock
图片来自shutterstock。
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