泰恩康(301263.SZ):控股子公司CKBA軟膏白癜風適應症獲得II期臨牀試驗研究初步結果且達到預期目標
格隆匯8月4日丨泰恩康(301263.SZ)公佈,近日,廣東泰恩康醫藥股份有限公司控股子公司江蘇博創園生物醫藥科技有限公司(簡稱“博創園”)自主研發的1類創新藥CKBA軟膏白癜風適應症II期臨牀試驗已於近日完成數據整理並揭盲。初步結果表明,CKBA軟膏在非節段型白癜風患者中表現出積極的療效和良好的安全性,試驗結果理想,達到預期目標,支持繼續開展III期確證性臨牀試驗,相關研究數據也將在近期提交CDE進行突破性療法申請和註冊臨牀的溝通交流。
初步研究結果顯示,高劑量組CKBA軟膏1.5%BID劑量組的面頸部白癜風評分指數達到F-VASI50和F-VASI25的受試者比例均優於溶媒組(安慰劑組),其中疾病好轉及不同程度複色患者佔比爲36%(18/50)。本項臨牀試驗,試驗用藥品相關不良事件(TEAE)主要爲瘙癢、紅斑,嚴重程度均爲1-2級,較爲輕微,其中高劑量組CKBA軟膏1.5%BID劑量組和溶媒組(安慰劑組)的發生率分別爲18%和12%;未發生與試驗用藥品相關的嚴重不良事件(SAE)。表明CKBA軟膏具有良好的安全性和耐受性。
本次臨牀研究初步數據結果顯示,CKBA軟膏高劑量組面頸部白癜風評分指數優於安慰劑組,具有明顯療效,同時報告不良事件發生率低、無與試驗用藥品相關的嚴重不良事件(SAE)。CKBA作爲非免疫抑制劑,有望爲需要長期用藥的白癜風患者提供一種安全有效的創新治療方案。
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