中國抗體-B(03681.HK):SM17在美國I期臨牀試驗完成首位健康受試者給藥
格隆匯6月15日丨中國抗體-B(03681.HK)宣佈,於2022年6月14日(美國東部當地時間)在美國進行的SM17I期FIH(首次人體)臨牀試驗中,已成功向首位健康受試者給藥。I期研究為單次遞增劑量(SAD)及多次遞增劑量(MAD),旨在評估SM17在健康受試者中的安全性、耐受性及藥物代謝動力學。
SM17為以白細胞介素17受體B(IL-17RB)為靶點的人源化IgG4-k單克隆抗體。SM17通過與2型先天淋巴細胞(ILC2s)上的IL-17RB結合可抑制Th2細胞的免疫反應,從而阻止人白細胞介素25(IL-25)誘發的一連串反應。IL-25為一類關鍵的"警戒素",已被證明與氣道細胞的病毒感染反應以及過敏性疾病如哮喘的病理變化有關。患有未受控制的嚴重哮喘的患者,會承受哮喘反覆發作及住院的風險;而未受控制的嚴重哮喘疾病會引發羣體死亡率╱患病率升高、生活質素下降以及醫療支出增加等社會性問題。目前已獲批上市的嚴重哮喘療法(包括生物製劑),可一定程度降低哮喘年度發作。然而,嚴重哮喘的有效治療仍存在未滿足的醫療需求,尤其是對當前療法無應答的患者而言。我們相信靶向Th2炎性細胞因數通路的上游(例如IL-17RB)的療法,預計將對氣道炎症相關的病理變化產生廣譜的作用並改善疾病病情;我們相信SM17在哮喘治療未被滿足醫療需求中的巨大潛力。
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