李氏大藥廠(00950.HK)附屬圓滿完成環孢黴素A眼科凝膠的II期臨牀研究
格隆匯10月30日丨李氏大藥廠(00950.HK)公佈,於2019年10月30日,公司間接非全資附屬公司China Ophthalmology Focus Limited於中國自主研發的產品環孢黴素A眼科凝膠的II期臨牀研究已完滿完成。頂線數據顯示,與市售環孢黴素A眼科乳劑相比,實驗藥物具有相似或更好的療效趨勢。
最近完成的臨牀研究為二期、隨機、單盲、陽性對照劑量探索性,以評估環孢黴素A眼科凝膠治療乾眼症(乾燥性角膜結膜炎)的有效性和安全性。這項研究的目的是探討和比較使用環孢黴素A乳劑的專利眼科凝膠製劑(目前在西方市場上可購買的配方)中,環孢黴素A在使用不同劑量與用藥頻率在治療上述適應症中的功效性和安全性,並初步確定跟進臨牀研究設計的最佳條件。此項臨牀研究自中國13箇中心招募了240名患者。
當前試驗的頂線數據顯示,新的環孢黴素A眼科凝膠製劑配方(0.3g:0.15mg,每天一次)與目前西方市場上的乳劑配方具有相似或更好功效的趨勢。公司相信,環孢黴素A眼科凝膠能夠很好地解決尚沒有眼科環孢黴素A的中國乾眼症患者的的未滿足醫療需要。公司已經花了10年的時間開發了受專利保護的環孢黴素A專利眼科凝膠配方。頂線數據證實了公司對開發這種創新產品的承諾。
公司計劃與中國藥物評估中心會面,討論並商定環孢黴素A眼科凝膠臨牀試驗的III期方案。這項關鍵性研究預計將在2020年年初開始招募患者。
據悉,環孢黴素A是天然的環狀多肽免疫抑制劑。它擔當鈣調神經磷酸酶抑制劑,抑制T淋巴細胞釋放促炎性細胞因子。環孢黴素A眼科凝膠是專利產品,在臨牀前研究中顯示出比乳劑配方有更出色的藥代動力學特性。目前正在中國開發用於治療乾燥性角膜結膜炎(乾眼症)。
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