康诺亚-B(02162):CM512(TSLP x IL-13双抗)注射液用于慢性鼻窦炎伴鼻息肉患者的II期临床试验达到所有研究终点

智通财经
Aug 10

智通财经APP讯,康诺亚-B(02162)发布公告,公司自主研发的1类新药CM512注射液治疗慢性鼻窦炎伴鼻息肉(CRSwNP)的II期临床研究已完成数据揭盲及初步统计分析。

结果显示:1、CM512达到了全部研究终点,各剂量组疗效表现相当。CM512快速起效,给药第4周即可快速缩小鼻息肉同时显著改善鼻塞,并促进嗅觉功能恢复。给药一针疗效可维持半年,24周鼻息肉评分(NPS)较基线变化显著优于对照组,同时明显减轻整体鼻窦腔炎症。2、在CRSwNP患者中,CM512所有剂量组均展现出良好的安全性和耐受性,抗药抗体(ADA)的发生率极低。治疗期间不良事件(TEAEs)发生率与安慰剂组相当,CM512组未发生严重不良事件。

详细数据未来将于国际学术期刊或学术会议进一步公布。

基于此II期结果,公司正在快速启动CM512注射液治疗CRSwNP的临床III期研究,并明确300mg,半年给药一次(Q24W)为用药方案。

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