Biogen在AAIC 2026上公布了其抗tau反义寡核苷酸候选药物Diranersen(BIIB080)的详细II期CELIA试验数据,显示在早期阿尔茨海默病患者中,Diranersen显著降低脑脊液和脑内tau蛋白,并在多个临床指标上减缓了认知衰退。该研究还显示,60 mg剂量每六个月给药一次效果最佳,尽管未达到主要剂量反应终点,但所有剂量组均优于安慰剂。Diranersen在所有剂量组中均表现出强劲的tau减少,且安全性良好,无淀粉样蛋白相关成像异常(ARIA),因此Biogen计划推进III期开发。这是首次在II期试验中观察到tau定向疗法同时减少CSF总tau和脑内tau病理的临床证据,为tau靶向疗法开辟了新路径。
Sources:
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