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
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.
周四收盘后，武田制药株式会社（纽约证券交易所代码：TAK）公布了一项评估口服食欲素受体2（OX2R）激动剂 TAK-861 的2b期试验的主要结果，该试验评估了对1型发作性睡病患者的口服食欲素受体2（OX2R）激动剂。
Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence (excessive daytime sleepiness) classified into two different types:
发作性睡病是一种慢性、罕见的中枢性睡眠过度神经系统疾病（白天过度嗜睡），分为两种不同的类型：
- 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 型发作性睡病（NT1）是由食欲素神经元大量流失导致食欲素缺乏引起的。
- 2型发作性睡病（NT2），食欲素水平通常正常。
Two separate Phase 2b studies were conducted in NT1 and NT2.
分别对NT1和NT2进行了两项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).
对 112 名患者进行 TAK-861 评估的 NT1 试验 TAK-861-2001 显示，与安慰剂相比，第 8 周觉醒的客观和主观指标均有统计学意义且具有临床意义的改善，包括主要终点维持觉醒测试（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.
关键次要终点（包括爱普沃斯睡眠量表和每周崩解率）的改善具有统计学意义且具有临床意义，与主要终点一致。
Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 in the first half of its fiscal year 2024.
武田计划在其 2024 财年的上半年启动 NT1 的 TAK-861 全球三期试验。
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 中推进 TAK-861。正在进一步分析数据，以确定食欲素正常人群的下一步行动。
TAK-861 was generally safe and well tolerated in both trials. No treatment-related serious adverse events were reported.
在两项试验中，TAK-861 总体上是安全的，耐受性良好。未报告与治疗相关的严重不良事件。
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.
上周，武田制药公布的2023年第三季度核心净利润为2359亿日元，按固定汇率下降9.4％和9.5％。
Price Action: TAK shares are up 1.29% at $14.18 on the last check Friday.
价格走势：在周五的最后一次支票中，TAK股价上涨1.29％，至14.18美元。
Photo via Wikimedia Commons
照片来自维基共享资源