京新藥業(002020.SZ):EVT201膠囊Ⅲ期臨牀試驗成功實施入組
格隆匯8月21日丨京新藥業(002020.SZ)公佈,公司於2020年4月收到國家藥品監督管理局簽發的藥物臨牀試驗通知書,批准公司申報的EVT201膠囊進行Ⅲ期臨牀試驗。近日,公司按照藥物臨牀試驗通知書要求完成EVT201膠囊Ⅲ期臨牀試驗的準備工作,成功實施臨牀入組。
EVT201屬於新型GABAa受體的部分激動劑,能迅速產生激活作用,但又避免過度激活。目前失眠障礙治療藥物首選新型非苯二氮卓類為主,如唑吡坦、右佐匹克隆等,均屬於選擇性GABAa激動劑。據米內網數據,2018年中國公立醫療機構終端鎮靜催眠藥銷售額為42.06億元。
從前期EVT201膠囊臨牀Ⅱ期試驗結果看,EVT201膠囊安全性好,無嚴重不良事件。用於III期臨牀試驗的2.5mg劑量組能有效延長受試者的總睡眠時間(TST)(P<0.05)。
根據前期臨牀試驗結果及臨牀試驗通知書要求,公司繼續推進EVT201膠囊的Ⅲ期臨牀試驗。截止公告日,Ⅲ期臨牀已有兩例受試者成功入組,後續公司將繼續有序推進EVT201膠囊的Ⅲ期臨牀試驗相關工作。
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