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康方生物-B(09926.HK):AK120治療中重度特應性皮炎Ib期臨試完成首例患者入組
格隆匯 10-16 08:11

格隆匯 10 月 16日丨康方生物-B(09926.HK)發佈公告,公司自主研發的IL-4R單克隆抗體注射液(研發代號:AK120)在新西蘭和澳大利亞開展的用於治療中重度特應性皮炎多劑量遞增Ib期臨牀試驗完成首例患者入組。

目前,AK120在健康受試者單劑量遞增Ia期臨牀研究已經爬坡至最高劑量600毫克組。研究結果顯示,單次皮下注射給藥後,AK120具有很好的耐受性。在AK120單次給藥(300毫克)7天后,作為特應性皮炎的生物標誌物,受試者血液中的胸腺激活和調節趨化因子(“TARC/CCL17”)水平,與安慰劑組相比已有統計學意義的顯著降低。

AK120是公司自主研發的靶向IL-4R的新型自身免疫疾病治療藥物,擬用於治療特應性皮炎、哮喘等過敏性疾病。AK120通過抑制雙重細胞因子IL-4和IL-13的生物學活性,以達到臨牀治療過敏性自身免疫疾病的功效。由賽諾菲(Sanofi)和再生元(Regeneron)公司共同開發的同靶點藥物Dupilumab(商品名:Dupixent)已被美國食品藥品監督管理局(FDA)批准用於治療中重度特應性皮炎、中重度哮喘及慢性鼻炎,2019年Dupixent的銷售額達到20.7億歐元。

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