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Press release
2019年03月22日 09時00分
Source:
Eisai
エーザイ、BAN2401について早期アルツハイマー病を対象とした臨床第III相試験を開始
東京, 2019年03月22日 - (JCN Newswire) - エーザイ株式会社(本社:東京都、代表執行役 CEO:内藤晴夫)は、このたび、抗アミロイドβ(Aβ)プロトフィブリル抗体 BAN2401 について、早期アルツハイマー病(AD)を対象としたグローバルな臨床第III相試験(Clarity AD/301 試験)が開始されたことをお知らせします。BAN2401 について、当社はバイオジェン・インク (Nasdaq: BIIB、本社:米国マサチューセッツ州ケンブリッジ、以下 バイオジェン)と共同開発を行っています。
Clarity AD は、アミロイドの脳内蓄積が確認されたアルツハイマー病による軽度認知障害(MCI due to AD)および軽度アルツハイマー病(総称して早期 AD)患者様 1,566 人を対象とした、プラセボ対照、二重盲検、並行群間比較、無作為化グローバル臨床第III相試験です。臨床第II相試験(201 試験)結果に基づく規制当局とのミーティングを踏まえ、BAN2401 の申請に必要な 1 本の臨床第III相試験が開始されました。実薬群は、BAN2401 10 mg/kg バイウィークリー投与の 1 用量であり、被験者はプラセボ投与群または実薬群の1:1に割り付けられます。プライマリーエンドポイントは、ベースラインから投与18 カ月までの CDR-SB(Clinical Dementia Rating Sum of Boxes)の変化とし、キーセカンダリーエンドポイントとして、アミロイド PET 測定による脳内アミロイド蓄積、ADCOMS(Alzheimer's Disease Composite Score)および ADAS-cog(Alzheimer's Disease Assessment Scale-cognitive subscale)のベースラインから投与 18 カ月までの変化が設定されています。
当社は、世界的に大きな課題となっているアルツハイマー病に対する革新的な治療薬を一日も早く創出し、アンメット・メディカル・ニーズの充足と患者様とそのご家族のベネフィット向上に、より一層貢献してまいります。
本リリースの詳細は下記をご参照ください。
https://www.eisai.co.jp/news/2019/pdf/news201919pdf.pdf
概要:エーザイ株式会社
詳細はwww.eisai.co.jpをご覧ください。
Source: Eisai
セクター: バイオテック
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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