山東新華製藥股份(00719.HK):治療輕至中度阿爾茲海默病的OAB-14幹混懸劑完成Ⅱ期臨牀中國首例患者入組
格隆匯6月19日丨山東新華製藥股份(00719.HK)公佈,近日,公司治療輕至中度阿爾茲海默病的OAB-14幹混懸劑完成Ⅱ期臨牀中國首例患者入組。
OAB-14是新華製藥與瀋陽藥科大學合作研製的具有自主知識產權的新化學結構創新藥,屬於1類創新藥,適應症擬定爲輕至中度阿爾茨海默病(AD)。
2019年本公司開始合作進行非臨牀研究,研究結果表明OAB-14能顯著改善APP/PS1雙轉基因AD模型小鼠學習記憶和社交活動等多種行爲障礙。OAB-14抗AD作用,主要與清除腦內Aβ有關,也與中樞抗炎、抗氧化、抑制神經元凋亡等多靶點的機制有關。OAB-14能顯著減少腦內β澱粉樣蛋白沉積,降低Tau蛋白過度磷酸化,同時,保護大腦皮層及海馬神經細胞及突觸結構與功能,其安全性藥理、毒理學研究未發現與受試物相關的組織病理學異常改變。
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