
安基生技自主研發之新藥AJ201已獲美國FDA同意進入脊髓延髓性肌肉萎縮症(SBMA)第三期人體臨床試驗,成為全球唯一進入此階段且具First-in-Class作用機轉之SBMA創新藥。試驗規劃全球收案200名病患,公司將以此推進國際授權洽談以最大化藥價值。
AI-generated summary
SBMA是一種主要影響男性的罕見遺傳性神經肌肉退化疾病,男性盛行率約為四萬分之一,目前全球尚無核准之有效治療藥物,歐美日已有逾1.2萬名確診患者。
安基生技董事長黃文英。(資料照)
〔記者陳永吉/台北報導〕興櫃新藥研發公司安基生技(7754)上週五(3)公告,該公司自主研發之核心新藥AJ201,向美國食品藥物管理局(FDA)提出之脊髓延髓性肌肉萎縮症(SBMA,又稱甘迺迪氏症)第三期人體臨床試驗申請,經FDA 30天審查期屆滿且未提出意見,安基將正式於美國開展SBMA病患之第三期臨床試驗。AJ201成為現階段全球唯一進入第三期臨床試驗、具First-in-Class(同類首創)作用機轉之SBMA創新藥。
安基表示,SBMA是一種主要影響男性的罕見遺傳性神經肌肉退化疾病,保守估計男性盛行率約為四萬分之一;由於初期症狀容易與其他運動神經元疾病混淆,歐美日臨床專家普遍認為實際患者人數遭到低估,且目前全球尚無核准之有效治療藥物。根據國際策略顧問公司L.E.K.調查,歐美日已有逾1.2萬名確診患者。
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安基指出,AJ201透過促進突變雄性素受體(mAR)蛋白降解及活化Nrf2抗氧化路徑之多重機轉,有別於現有研究方向,且已取得美國FDA及歐盟EMA甘迺迪氏症孤兒藥認定(ODD)並獲美國FDA之快速審查認定。本次三期試驗規劃全球收案200名病患,實際時程將依收案進展調整。
安基表示,AJ201正式進入第三期臨床試驗,代表產品開發已邁入新藥上市前最關鍵階段,公司將以此重大進展為基礎,積極推進AJ201國際授權洽談,在維持全球智慧財產主導權的前提下,爭取最有利之合作條件, 將AJ201價值最大化,並為投資人持續創造價值。
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AI outlook — possibilities, not facts
安基生技將在未來數月內啟動SBMA第三期臨床試驗的全球收案工作
Very likely · Within months
安基生技將積極推進AJ201的國際授權洽談,以最大化藥物價值
Likely · Within months

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