First Advanced Oral Treatment For Asthma - Sanofi's Investigational Drug Shows Potential
First Advanced Oral Treatment For Asthma - Sanofi's Investigational Drug Shows Potential
Wednesday, Sanofi SA (NASDAQ:SNY) reported results from the Phase 2 study of oral rilzabrutinib in adult patients with uncontrolled moderate-to-severe asthma.
賽諾菲公司（納斯達克股票代碼：SNY）週三公佈了口服rilzabrutinib治療未受控制的中度至重度哮喘成年患者的2期研究結果。
Two doses of rilzabrutinib, 800 mg daily and 1200 mg daily, were studied.
研究了兩劑利扎布替尼，每日800毫克，每天1200毫克。
The data showed that treatment with oral rilzabrutinib at both high and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma.
數據顯示，無論是高劑量還是低劑量口服rilzabrutinib進行治療，均可減少哮喘失控（LOAC）事件（主要終點）的數量，並改善未受控制的中度至重度哮喘成年患者的症狀。
These results were presented at the 2024 American Thoracic Society (ATS) International Conference in San Diego and will support the phase 3 program, in which a twice-daily dose of rilzabrutinib will be studied for moderate-to-severe asthma.
這些結果已在聖地亞哥舉行的2024年美國胸科學會（ATS）國際會議上公佈，並將支持第三階段計劃，在該計劃中，將研究每天兩次劑量的利扎布替尼治療中度至重度哮喘。
In this proof-of-concept study, treatment with high and low doses of rilzabrutinib resulted in a 36% and 25% relative risk reduction in loss of asthma control (LOAC) events, respectively, at week 12 (primary endpoint).
在這項概念驗證研究中，在第12周（主要終點），使用高劑量和低劑量的利扎布替尼治療使哮喘失去控制（LOAC）事件的相對風險分別降低了36％和25％。
Significant and clinically meaningful improvements in asthma symptoms were also observed with a -0.54/-0.59 LS mean difference in the asthma control questionnaire.
哮喘控制問卷的平均差異爲-0.54/-0.59 LS，還觀察到哮喘症狀明顯改善，具有臨床意義。
Rilzabrutinib high and low doses were well tolerated over 12 weeks of treatment with no events of cytopenia, hemorrhagic events, or atrial fibrillation and no imbalance in liver function tests.
Rilzabrutinib的高劑量和低劑量在治療12周內均表現良好，沒有出現血細胞減少、出血事件或心房顫動，肝功能測試也沒有失衡。
Treatment-emergent adverse events (TEAEs) occurring with higher frequency with rilzabrutinib versus placebo were diarrhea (10.9% and 9.4% with rilzabrutinib high and low dose, versus 0% and 3.1% with matching placebo, respectively).
與安慰劑相比，利扎布替尼發生的治療緊急不良事件（TEAE）頻率更高，是腹瀉（高劑量和低劑量利扎布替尼分別爲10.9％和9.4％，而配套安慰劑分別爲0％和3.1％）。
Recently, GSK plc (NYSE:GSK) said headline results from the phase 3 clinical trials SWIFT-1 and SWIFT-2 of depemokimab met their primary endpoints of a reduction in the annualized rate of clinically significant exacerbations (asthma attacks) over 52 weeks versus placebo.
最近，葛蘭素史克公司（紐約證券交易所代碼：GSK）表示，depemokimab的3期臨床試驗 SWIFT-1 和 SWIFT-2 的主要結果達到了其主要終點，即與安慰劑相比，52周內臨床顯著惡化（哮喘發作）的年化發生率有所降低。
Price Action: SNY shares are up 1.97% at $49.92 at the last check on Wednesday.
價格走勢：在週三的最後一次支票中，紐約證券交易所股價上漲1.97％，至49.92美元。
譯文內容由第三人軟體翻譯。