バイオジェン:フェーズ2 CELIA試験のトップライン結果、diranersenでタウ蛋白の減少と認知機能への効果を示す

The Phase 2 CELIA study met key secondary and exploratory endpoints, demonstrating robust reductions in CSF tau and tau-PET pathology plus slowing of clinical decline across all doses, particularly the 60 mg q24w arm. Although the primary endpoint (dose-response on CDR-SB at Week 76) was not met, the data provide the first randomized Phase 2 evidence that a tau-directed ASO can impact both biomarkers and cognition in early Alzheimer’s disease, prompting Biogen to advance the program to registrational development.

主要事実

提出: 2026年5月14日 10:59
イベント: トップライン結果
方向: ポジティブ
企業: BIIBバイオジェン
アセット: diranersen
出典: 企業プレスリリース
信頼度: 出典あり

出典の抜粋

Topline Results from Phase 2 CELIA Study of Diranersen (BIIB080): First Study to Show Reduction in Tau Pathology and Cognitive Benefit in Patients with Early Alzheimer’s Disease Robust reductions in tau pathology were observed across all studied doses, with results generally consistent with those observed in the Phase 1b study 1 Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly at the lowest dose The safety and tolerability profile of diranersen was generally consistent with the Phase 1b study 1 CELIA is an 18-month Phase 2 randomized, placebo-controlled, dose-ranging study evaluating diranersen, a tau-targeting antisense oligonucleotide (ASO) Data will be presented at the Alzheimer’s Association International Con

企業プレスリリース