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右美托咪定舌下薄膜BXCL501治疗精神分裂症:III期临床成功

2020-07-21 MedSci原创 MedSci原创

BioXcel Therapeutics宣布其BXCL501治疗精神分裂症和其他双相情感障碍,III期研究SERENITY I和SERENITY II达到了主要和次要终点。

BioXcel Therapeutics周一宣布,实验药物BXCL501治疗精神分裂症和其他双相情感障碍患者的III期研究SERENITY I和SERENITY II,达到了主要和次要终点。该公司因这一消息股价飙升33%,BioXcel计划在2021年第一季度向FDA提交营销申请。

See the source image

图片来源:https://ir.bioxceltherapeutics.com/all-sec-filings/content/0001047469-18-001452/a2234762z424b4.htm?TB_iframe=true&height=auto&width=auto&preload=false

BXCL501是镇静剂右美托咪定(一种用于治疗急性躁动的选择性α-2a受体激动剂)的舌下薄膜制剂。根据BioXcel的说法,与安慰剂相比,该疗法的低剂量组和高剂量组在两个小时,显著降低了兴奋性成分(PEC)得分(这两项研究的主要终点),数据具有“高度统计显着性和临床意义”。

迅速、显著降低患者躁动

首席执行官Vimal Mehta表示:“两个患者人群中均显示出快速而强劲的躁动减少,我们感到非常高兴。这些结果表明BXCL501可能具有在多种情况下治疗躁动的潜力。”

SERENITY I招募了381例与精神分裂症或分裂情感障碍有关的躁动患者,随机接受120 mcg或180 mcg BXCL501或安慰剂的治疗。SERENITY II招募了378例与I型或II型躁郁症相关的躁动患者,随机分配接受两种剂量之一的BXCL501或安慰剂。

结果显示,在SERENITY I中,服用180 mcg和120 mcg剂量BXCL501患者的PEC得分分别降低了10.3点和8.5点,而安慰剂降低了4.8点。响应率定义为PEC得分降低40%以上的患者百分比,其中180 mcg组为87%,120 mcg组为67%,安慰剂为34%。同样,在SERENITY II中,BioXcel报告了高剂量,低剂量和安慰剂组的PEC得分分别降低了10.4、9.1和5.0分。180 mcg组的响应率为85%,120 mcg组为69%,安慰剂为37%。

最快20分钟即可看到效果

两项研究均达到了关键的次要终点,双相情感障碍患者在两种剂量下的PEC评分降低均始于20分钟,而精神分裂症患者的高剂量组PEC评分降低也始于20分钟。该公司表示:“疗效终点已经确定,治疗后反应时间持续至少四个小时。”

同时BXCL501的耐受性良好,无严重不良事件。最常见的副作用是嗜睡,超过75%的事件被认为是轻度的。

原始出处:

https://www.firstwordpharma.com/node/1741715?tsid=4

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    2021-01-16 juliusluan78
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