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諾誠健華自主研發的YK2抑制劑ICP-332 治療中重度特應性皮炎II期研究達到主要終點
諾誠健華今天宣佈,公司自主研發的新型酪氨酸激酶2(Tyrosine Kinase 2, TYK2)抑制劑ICP-332治療中重度特應性皮炎(AD)II期臨牀研究達到主要終點。在接受治療4周的患者中,ICP-332展示了卓越的有效性和安全性。ICP-332在80毫克和/或120毫克劑量組達到了多個有效性終點,包括EASI (濕疹面積和嚴重程度指數)50、EASI 75、EASI 90(EASI評分較基線改善≥50%,75%,90%)及研究者整體評估(IGA) 0/1(即皮損完全清除或基本清除)等。在每日一次80 毫克 和 120 毫克兩個劑量組中,EASI 評分較基線的平均百分比變化分別達到 78.2% 和 72.5%,與安慰劑組的 16.7%相比,具備顯著的統計學差異(p<0.0001)。這兩個劑量組 EASI 75(疾病至少改善 75%)評分較基線的百分比變化分別達到 64%和64%,而安慰劑組僅為 8%(p<0.0001)。ICP-332 顯示出良好的耐受性和安全性,治療相關不良事件 (TRAE) 均為輕度或中度,與安慰劑組相當。目前,全球尚無TYK2抑制劑獲批用於治療特應性皮炎。根據 Pharma Intelligence 相關數據,特應性皮炎是一種主要自身免疫性疾病,數以百萬計的患者存在巨大的未被滿足的醫療需求,預計到 2030 年全球市場潛力將達到100 億美元。ICP-332的II期臨牀試驗是一項隨機、雙盲、安慰劑對照的研究,旨在評估在中重度特應性皮炎患者中的安全性、有效性、藥代動力學和藥效學特性。
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