Good News For Sleep Disorder Patients - Takeda's Therapy Shows Promise In Mid-Stage Study
Good News For Sleep Disorder Patients - Takeda's Therapy Shows Promise In Mid-Stage Study
The NT1 trial TAK-861-2001 evaluating TAK-861 in 112 patients demonstrated a statistically significant and clinically meaningful improvement in objective and subjective measures of wakefulness compared to placebo at week 8, including on the primary endpoint Maintenance of Wakefulness Test (p < 0.001). Thursday after close, Takeda Pharmaceutical Co Ltd (NYSE:TAK) released topline results from a Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1.
週四收盤後，武田製藥株式會社（紐約證券交易所代碼：TAK）公佈了一項評估口服食慾素受體2（OX2R）激動劑 TAK-861 的2b期試驗的主要結果，該試驗評估了對1型發作性睡病患者的口服食慾素受體2（OX2R）激動劑。
Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence (excessive daytime sleepiness) classified into two different types:
發作性睡病是一種慢性、罕見的中樞性睡眠過度神經系統疾病（白天過度嗜睡），分爲兩種不同的類型：
- Narcolepsy type 1 (NT1) is caused by a significant loss of orexin neurons with a resulting lack of orexin.
- Narcolepsy type 2 (NT2), where orexin levels are generally normal.
- 1 型發作性睡病（NT1）是由食慾素神經元大量流失導致食慾素缺乏引起的。
- 2型發作性睡病（NT2），食慾素水平通常正常。
Two separate Phase 2b studies were conducted in NT1 and NT2.
分別對NT1和NT2進行了兩項2b期研究。
The NT1 trial TAK-861-2001 evaluating TAK-861 in 112 patients demonstrated a statistically significant and clinically meaningful improvement in objective and subjective measures of wakefulness compared to placebo at week 8, including on the primary endpoint Maintenance of Wakefulness Test (p < 0.001).
對 112 名患者進行 TAK-861 評估的 NT1 試驗 TAK-861-2001 顯示，與安慰劑相比，第 8 周覺醒的客觀和主觀指標均有統計學意義且具有臨床意義的改善，包括主要終點維持覺醒測試（p
Improvements in key secondary endpoints, including the Epworth Sleepiness Scale and Weekly Cataplexy Rate, were statistically significant and clinically meaningful, consistent with the primary endpoint.
關鍵次要終點（包括愛普沃斯睡眠量表和每週崩解率）的改善具有統計學意義且具有臨床意義，與主要終點一致。
Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 in the first half of its fiscal year 2024.
武田計劃在其 2024 財年的上半年啓動 NT1 的 TAK-861 全球三期試驗。
At this time, Takeda does not plan to advance TAK-861 in NT2. Data are being further analyzed to determine the next steps in orexin normal populations.
目前，武田不打算在 NT2 中推進 TAK-861。正在進一步分析數據，以確定食慾素正常人群的下一步行動。
TAK-861 was generally safe and well tolerated in both trials. No treatment-related serious adverse events were reported.
在兩項試驗中，TAK-861 總體上是安全的，耐受性良好。未報告與治療相關的嚴重不良事件。
Last week, Takeda Pharmaceutical reported a third-quarter 2023 core net profit of ¥235.9 billion, down 9.4% and 9.5% on constant currency.
上週，武田製藥公佈的2023年第三季度核心淨利潤爲2359億日元，按固定匯率下降9.4％和9.5％。
Price Action: TAK shares are up 1.29% at $14.18 on the last check Friday.
價格走勢：在週五的最後一次支票中，TAK股價上漲1.29％，至14.18美元。
Photo via Wikimedia Commons
照片來自維基共享資源
