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
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.
週五，格蘭史密斯克萊恩有限公司（紐交所：GSK）發佈了MATINEE第三期臨床試驗的頭條結果，評估了Nucala（美妥拉珠單抗）在慢性阻塞性肺疾病（COPD）或吸菸者肺中靶向白細胞介素-5（IL-5）的療效。
The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema who were receiving optimized inhaled maintenance therapy.
該試驗招募了慢性支氣管炎和/或肺氣腫具有廣泛臨床表現的COPD患者，這些患者正在接受優化的吸入維持治療。
Also Read: Amgen/AstraZeneca Say Asthma Drug Shows Activity In Another Lung Disease Across Broad Patient Population.
此外閱讀：安進/阿斯利康表示喘息藥物在廣泛的患者群體中對另一種肺部疾病表現出活性。
Participants were also required to have evidence of type 2 inflammation characterized by raised blood eosinophil count.
參與者還需要有第2型炎症的證據，其特點是血液嗜酸性粒細胞計數增高。
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通過加用Nucala到吸入維持治療中，達到了主要終點，並且研究結果顯示，與安慰劑相比，治療104周的患者中，中/重度加重的年化發生率有統計學意義和臨床意義的降低。
The preliminary safety results are consistent with the known safety profile of Nucala. Further analysis of these data is ongoing.
初步的安全性結果與Nucala已知的安全性概況一致。進一步分析這些數據正在進行中。
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在全球範圍內影響3億多人，其中最多40%的患者出現血液嗜酸性粒細胞計數增高的第2型炎症，這導致加重。
The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities.
MATINEE的全部結果將在將來的科學大會上公佈，並將用於與監管機構的持續討論。
Nucala is already approved as an add-on, prescription maintenance treatment for patients six and older with severe eosinophilic asthma.
Nucala已經獲得批准，作爲附加的處方維持治療，用於六歲及以上患有嚴重嗜酸性哮喘的患者。
Nucala is currently not indicated for COPD anywhere in the world.
Nucala目前在全球範圍內沒有用於COPD的適應症。
The drug contributed 6% to GSK's 2023 sales, with revenue of 1.65 billion pounds, up 18% at CER year over year.
該藥物對GSK的2023年銷售額貢獻了6%，營業收入爲16.5億英鎊，同比按恒定匯率計算增長了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批准了維羅納製藥股份有限公司（NASDAQ：VRNA）的Ohtuvayre（ensifentrine）用於成年患者COPD的維持治療。
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
奧托維亞雷是一種具有新機制作用的吸入性產品，用於COPD的維持治療，已有20多年時間沒有出現過。
Price Action: GSK stock is up 0.86% at $43.50 during the premarket session at last check Friday.
股票價格行動：GSK股票在週五的盤前交易中上漲了0.86%，至43.50美元。
Photo via Shutterstock
圖片來自shutterstock。
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譯文內容由第三人軟體翻譯。