聖諾醫藥-B(02257.HK)：Sirnaomics基於GalNAc RNAi療法藥物STP122G用於抗凝血治療的I期臨牀研究已完成首例受試者給藥
格隆匯6月1日丨聖諾醫藥-B(02257.HK)宣佈，集團已完成STP122G用於抗凝血治療的I期臨牀試驗首例受試者系統給藥。STP122G是集團GalAhead™十一因子項目之一，該項目適用於廣泛的疾病適應症，如預防心房顫動、治療心房顫動導致的中風及免疫治療後的癌症患者、以及改善全膝關節置換恢復。
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STP122G於健康受試者進行皮下注射單次遞增劑量的安全性、耐受性和藥代藥動。本次臨牀試驗將比較五種不同劑量的STP122G(25 mg、50 mg、100 mg、200 mg、400mg)的安全性及耐受性，以為未來的研究選擇最佳劑量。本次臨牀研究計劃共招募40名受試者。
Sirnaomics執行董事兼首席醫務官Michael Molyneaux博士表示，「本次I期臨牀研究將重點關注各劑量的STP122G(十一因子計劃)的安全性，將使公司可以檢測抗凝效果及十一因子的減少。上述結果將使我們能夠更深入地瞭解STP122G的療效，以確定未來使用公司的十一因子項目技術的安全性及有效劑量。成功減少十一因子的活性將使我們能夠選擇進入更多需要抗凝血治療領域以控制或預防疾病狀態，如心房顫動、骨科手術患者的血凝塊預防及接受透析治療的終末期腎病患者的血栓預防。」
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：「STP122G是本公司第一個基於GalAhead?的RNAi候選藥物，其抗凝血治療的潛力及顯着的療效已於非人靈長類動物模型獲得充分的驗證。隨着該藥物I期臨牀研究的開展及完成首例受試者給藥，我們不僅僅是幫助推進抗凝血療法的發展，並且也為在凝血障礙領域中大量未得到滿足的廣大患者羣體帶來希望。」
STP122G被認為是第三代十一因子抗凝血藥物，因為前幾代藥物並不能完全防止凝血障礙患者的出血情況。STP122G是一種十一因子抑制劑，該靶點僅參與內源性凝血過程，不會影響受傷或手術操作引起的凝血過程。因此，STP122G被認為比之前所有抗凝血藥物具有更良好的安全性。目前有三種類型的十一因子抑制劑已經處於市場化或臨牀試驗階段，包括STP122G，它是一種基於RNA的小分子單克隆抗躰治療方法。作為一種基於公司GalAhead™遞送平台的RNA療法候選藥物，STP122G以肝細胞為靶點，抑制十一因子的產生，具有長期療效及較小的出血風險。
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