益方生物(688382.SH):D-2570II期臨牀試驗取得積極的臨牀試驗結果
格隆匯12月3日丨益方生物(688382.SH)公佈,自主研發的靶向TYK2的新型口服選擇性抑制劑D-2570已於近日完成針對銀屑病的II期臨牀試驗,並取得了積極的臨牀試驗結果。
本試驗是一項多中心、隨機、雙盲、安慰劑對照的Ⅱ期臨牀研究,旨在評估D-2570治療中、重度斑塊狀銀屑病有效性和安全性。根據試驗方案,本次試驗共招募161名銀屑病患者入組,分組服用三個不同劑量的D-2570及安慰劑。試驗的主要終點為治療12周時銀屑病面積和嚴重程度指數(PASI)相對於基線至少改善75%的受試者百分比(PASI75)。本試驗初步結果顯示三個劑量組均達到了主要終點。其它一些療效終點,包括PASI90、PASI100(PASI評分較基線改善≥90%和≥100%),以及靜態臨牀醫生整體評估(sPGA)0/1(即皮損完全清除或基本清除)均有非常顯著的改善。
每日一次口服低、中、高劑量D-2570的患者,12周後PASI75應答率為85.0%-90.0%,顯著高於安慰劑組(12.5%),達到主要終點。三個劑量組PASI90應答率為70.7%-77.5%,安慰劑組為5.0%。PASI100應答率為39.0%-50.0%,安慰劑組為2.5%。sPGA0/1應答率為80.5%-87.5%,安慰劑組為20.0%。相比安慰劑組,各組的所有療效指標均具備顯著的統計學差異(P<0.001)。D-2570的各個劑量組均顯示出良好的耐受性和安全性,治療期間出現的不良事件和不良反應絕大部分為輕中度,總體發生率略高於安慰劑組,未出現嚴重不良事件(SAE)。與同類TYK2抑制劑安全性特徵相類似,未觀察到新出現的安全性信號。
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