恆瑞醫藥(600276.SH)：子公司的SHR0302鹼軟膏Ⅱ期臨牀研究所探索的鹼軟膏劑量均達到方案預設的有效終點指標
格隆匯10月11日丨恆瑞醫藥(600276.SH)公佈，近日，公司子公司瑞石生物醫藥有限公司(“瑞石生物”)研發的SHR0302鹼軟膏治療特應性皮炎的雙盲、賦形劑對照、Ⅱ/Ⅲ期無縫適應性設計臨牀研究RSJ10431(MARBLE23)(以下簡稱“RSJ10431研究”)，Ⅱ期臨牀研究所探索的鹼軟膏劑量0.5%、1.0%以及2.0%均達到方案預設的有效終點指標。
研究結果顯示，接受外用一天兩次0.5%、1.0%或2.0%的SHR0302鹼軟膏治療的患者達到濕疹面積和嚴重程度指數(以下簡稱“EASI”)總分較基線變化的百分比顯著高於賦形劑組。
RSJ10431研究是一項在輕度至中度特應性皮炎成人和青少年受試者中評價SHR0302鹼軟膏局部給藥的療效和安全性的隨機、雙盲、賦形劑對照、Ⅱ/Ⅲ期無縫適應性設計臨牀研究，由復旦大學附屬華山醫院徐金華教授擔任主要研究者。主要研究終點是治療第8周時EASI總分相對基線改變的百分比。
據悉，特應性皮炎是一種慢性炎症性皮膚病，病變複雜，臨牀表現和症狀多樣，典型的表現為皮膚色素沉着、乾燥、龜裂或鱗狀的斑塊，皮膚瘙癢，尤其是夜間瘙癢，嚴重影響患者的生活質量。研究表明，無論是兒童還是成人，特應性皮炎的患病率都呈逐步上升趨勢。
SHR0302鹼軟膏是一種外用、高選擇性的JAK1抑制劑，可通過抑制JAK1信號傳導發揮抗炎和抑制免疫的生物學效應。在國內，SHR0302相關劑型已開展銀屑病關節炎、強直性脊柱炎、類風濕性關節炎、潰瘍性結腸炎、中重度特應性皮的Ⅲ期臨牀試驗，以及白癜風、斑禿和克羅恩病的Ⅱ期臨牀試驗。在海外，SHR0302相關劑型在美國、歐洲、加拿大和澳洲已開展用於潰瘍性結腸炎、中重度特應性皮炎、斑禿和克羅恩病的國際多中心臨牀試驗。
截至目前，SHR0302相關項目累計已投入研發費用約為3.496億元。
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