聖諾醫藥-B(02257.HK):RNAi治療藥物STP122G用於治療凝血異常疾病的I期臨牀研究IND申請已獲美國FDA批准
格隆匯4月12日丨聖諾醫藥-B(02257.HK)發佈公吿,基於集團GalNAc十一因子項目STP122G的I期臨牀試驗已獲得美國食品藥物管理局(“美國FDA”)的監管許可,並將啟動該I期臨牀試驗。本次研究標誌着Sirnaomics首次將其專有的 GalNAc RNAi遞送平台技術GalAhead™應用於這一種siRNA候選藥物中,並對凝血異常疾病需求缺口巨大的患者羣體展開臨牀試驗。集團預計於2023年年中完成首位志願受試者給藥。
根據披露,十一因子是一種主要由肝臟肝細胞產生的酶,在體內的凝血鏈中發揮重要作用。由於良好的臨牀數據及其卓越的安全性,近期對十一因子作為抗凝血劑使用的熱度有所增加。其原因是降低十一因子僅影響內在凝血路徑,但同時不影響外在途徑及出血時間。十一因子的生成部位也使其成為基於GalNAc的 siRNA療法的理想靶點。本項I期、單中心、隨機、雙盲、安慰劑對照、序列分組研究旨在評估GalNAc-siRNA治療藥物STP122G的安全性、耐受性和藥代藥動, STP122G將對健康志願受試者進行皮下注射給藥。集團的目標是以十一因子為靶點用以治療抗凝血,如心房顫動、肺栓塞、深層靜脈血栓(DVT)及預防因手術而導致的深層靜脈血栓。
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