聖諾醫藥-B(02257.HK)：核酸干擾候選藥物STP707通過靜脈給藥用於原發硬化性膽管炎治療臨試申請獲FDA安全放行
格隆匯2月16日丨聖諾醫藥-B(02257.HK)發佈公吿，小干擾核糖核酸(siRNA)候選藥物STP707通過靜脈給藥用於原發硬化性膽管炎(PSC)治療的I期臨牀試驗申請(IND)已獲得美國食品藥品監督管理局(FDA)安全放行函。公司預計在2022年第二季度啟動I期研究，將在健康的受試者中通過靜脈輸注給藥來評價STP707的安全性、耐受性和藥代藥動。
STP707利用雙靶點RNAi抑制特性，配合多肽納米PNP(HKP+H)給藥製劑可通過靜脈給藥後靶向肝組織中特定的細胞類型，如肝竇血管內皮細胞(LSEC)和肝內巨噬細胞(Kupffer)，敲低細胞內TGF-β1和COX-2基因表達。當這兩種細胞過度表達TGF-β1和COX-2時，將嚴重影響肝臟組織纖維化的病理過程。一系列的臨牀前動物試驗表明，靜脈注射多肽納米制劑的TGF-β1和COX-2 siRNA後，可觀察到在肝臟組織中的靶點敲低導致降低組織纖維化活性。通過進一步的噬齒動物和非人類靈長動物模型中的臨牀前藥理及毒理研究，已經為STP707推進至臨牀試驗提供了安全可行的保證。
Sirnaomics創始人、董事會主席、執行董事、總裁兼首席執行官陸陽博士表示：“隨着公司的STP707用於原發硬化性膽管炎治療的臨牀試驗申請獲的FDA安全放行函，Sirnaomics將進一步研究這種對於PSC患者很有意義的治療方法。由於目前PSC是一種醫療選擇有限的罕見疾病，這會是一個重要的里程碑。我們將繼續開發多種核酸干擾藥物以滿足具有重大臨牀需求的適應症。”
Sirnaomics執行董事兼首席醫療官Michael Molyneaux博士補充道：“目前尚無被批准的療法能有效地改變PSC患者所經歷的漸進性肝臟纖維化。結果導致了大多數這類患者後來都很不幸地需要進行肝移植手術。現在，患者可以從這種罕見疾病的非手術治療方案中大大受益。我們前期研究成果表明，STP707在臨牀前模型中顯示了穩定的藥物作用。我們期望在即將進行的I期臨牀試驗中，會進一步瞭解這種治療PSC候選藥物的潛在劑量和安全性。”
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