智通财经APP获悉,百时美施贵宝(Bristol Myers Squibb)(BMY.US)今日宣布POETYK PsA-1和POETYK PsA-2试验的积极结果。这两项关键的3期临床试验评估了酪氨酸激酶2(TYK2)抑制剂Sotyktu(deucravacitinib)在活动性银屑病关节炎(PsA)成人患者中的疗效和安全性。试验结果显示,两项研究均达到主要终点,与安慰剂相比,接受Sotyktu治疗的患者在16周后达到ACR20(疾病体征和症状至少改善20%)的比例显著更高。新闻稿指出,这些顶线结果标志着Sotyktu首次在风湿性疾病中完成3期临床试验。
此外,POETYK PsA-1和POETYK PsA-2试验在第16周还达到了与PsA疾病活动相关的重要次要终点。Sotyktu在这两项试验中的整体安全性与其在治疗PsA的2期临床试验和中重度斑块状银屑病的3期临床试验中观察到的已知安全性一致。百时美施贵宝计划与关键研究者合作,在即将召开的医学会议上公布详细研究结果。
Sotyktu(deucravacitinib)是一种口服选择性别构TYK2抑制剂,具有独特的作用机制。它通过结合TYK2的调控域实现高度选择性,从而对TYK2及其下游功能进行别构抑制。Sotyktu在生理相关浓度下选择性抑制TYK2,在治疗剂量下不抑制JAK1、JAK2或JAK3。Sotyktu目前已在多个国家和地区获批用于治疗中重度斑块状银屑病成人患者。
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