{"schema_version":"1.0","type":"article","title":"Tau 拿到補考資格：Diranersen 主終點失敗，為什麼 Biogen 仍要進三期？","url":"https://drugnews.com.tw/articles/2026-08-03-diranersen-celia-tau-phase3.html","markdown_url":"https://drugnews.com.tw/articles/2026-08-03-diranersen-celia-tau-phase3.md","lang":"zh-Hant","date":"2026-08-03","publish_at":"2026-08-03T08:01:00+08:00","updated_at":"2026-08-03","category":"商業分析系列","topic":"商業分析系列","tags":["阿茲海默症","Tau","Diranersen","BIIB080","IONIS-MAPTRx","Biogen","Ionis","反義寡核苷酸","ASO","CDR-SB","臨床數據","新藥研發"],"summary":"CELIA 未達預設劑量反應主要終點，最低劑量卻在 CDR-SB 看到 26% 惡化減緩，CSF total tau 與 Tau PET 也同向下降。這些訊號足以讓 Biogen 與 Ionis 規劃三期，還不足以宣布 Tau 已成為第二條獲確認的疾病修飾路線。","key_points":[],"facts":[],"sections":["01｜先把試驗問題說對：CELIA 問的是劑量反應","02｜26% 從哪裡來？先看點數，再看百分比","03｜三層證據同方向，Tau 討論才會升溫","04｜降低生成，和過去清除 Tau 有何不同？","05｜安全性目前可接受，ARIA 仍不能保證為零","06｜別把 26% 和 Leqembi、Kisunla 直接排隊","07｜Biogen 為什麼還敢進三期？","08｜台灣讀者該看什麼？","09｜結論：Tau 拿到補考資格","參考資料","免責聲明"],"references":[{"title":"以下均為一級來源或官方試驗登錄。查證截止：2026-07-19。","source":"","date":"","url":""},{"title":"AAIC 2026 官方日程（London，2026/7/12–7/15）：","source":"","date":"","url":"https://aaic.alz.org/program/schedule.asp"},{"title":"ClinicalTrials.gov，CELIA（NCT05399888）：","source":"","date":"","url":"https://clinicaltrials.gov/study/NCT05399888"},{"title":"Biogen，CELIA Phase 2 完整資料：","source":"","date":"","url":"https://investors.biogen.com/node/30826"},{"title":"Ionis，diranersen／CELIA 公告：","source":"","date":"","url":"https://ir.ionis.com/node/34616"},{"title":"Alzheimer's Association，2026 藥物研發管線總覽：","source":"","date":"","url":"https://www.alz.org/news/2026/alzheimers-disease-drug-development-pipeline-is-growing"}],"images":[{"alt":"CELIA 的主要終點檢驗更高或更頻繁劑量是否帶來更大 CDR-SB 效益","url":"https://drugnews.com.tw/assets/articles/diranersen-celia-tau-phase3/figure-01.png"},{"alt":"最低劑量組在 CDR-SB 表現最好，但預設劑量反應主要終點仍未達","url":"https://drugnews.com.tw/assets/articles/diranersen-celia-tau-phase3/figure-02.png"},{"alt":"機制、生物標記與部分臨床結果同方向，仍不等於三期已證明患者效益","url":"https://drugnews.com.tw/assets/articles/diranersen-celia-tau-phase3/figure-03.png"},{"alt":"Diranersen 第三期必須回答訊號重現、認知與功能、劑量窗、安全性及治療背景五個問題","url":"https://drugnews.com.tw/assets/articles/diranersen-celia-tau-phase3/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/diranersen-celia-tau-phase3/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-08-03）。Tau 拿到補考資格：Diranersen 主終點失敗，為什麼 Biogen 仍要進三期？。https://drugnews.com.tw/articles/2026-08-03-diranersen-celia-tau-phase3.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{"en":"2026-08-03-diranersen-celia-tau-phase3-en.html"},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}