粉塵蟎滴劑特應性皮炎適應症獲得III期臨牀試驗總結報吿 我武生物(300357.SZ)終止“粉塵蟎滴劑特應性皮炎適應症”項目
格隆匯12月30日丨我武生物(300357.SZ)公佈，日前，公司已上市產品“粉塵蟎滴劑”(國藥準字S20060012，獲批適應症：用於粉塵蟎過敏引起的過敏性鼻炎、過敏性哮喘的脱敏治療)完成了“舌下含服“粉塵蟎滴劑”治療特應性皮炎的臨牀療效及安全性評價——多中心、隨機、雙盲、安慰劑平行對照的III期臨牀試驗”(簡稱“粉塵蟎滴劑特應性皮炎III期臨牀試驗”)，並形成了《粉塵蟎滴劑特應性皮炎III期臨牀試驗總結報吿》。
該研究的整體安全性分析結果顯示本品安全性良好，試驗組和對照組的不良事件和不良反應發生率接近，試驗組未發生嚴重不良反應。療效數據顯示，主要療效指標受試者在第27周—48週末使用外用糖皮質激素的累積天數，試驗組相比對照組有改善但未達到組間差異的統計學意義；次要療效指標之一，治療52週末的SCORAD評分相比篩選期的下降幅度，試驗組的結果優於對照組。研究者認為此整體療效結果未達到藥品監管部門審評所需要的標準，難以支持後續本品新適應症註冊申報。
研究者推測，整體療效結果未達到預期要求的主要原因是，本品真正的適用人羣應為粉塵蟎過敏引起的特應性皮炎患者。而迄今為止，臨牀診斷中尚無有效的手段可以較精準地識別出這樣的患者羣體，這導致了臨牀試驗中納入的部分受試者其特應性皮炎的病因可能不是粉塵蟎過敏，甚至與變應原無關，從而拖累了整體的療效數據。
“粉塵蟎滴劑”作為脱敏治療藥物，若可針對性地治療由粉塵蟎過敏導致的特應性皮炎患者，預計將獲得更佳的療效結果。但在實際的臨牀試驗操作中，因無有效篩選手段獲得對應的患者羣體，從而導致了該項目的III期臨牀試驗結果難以支持後續的本品申報註冊“特應性皮炎”新適應症。基於現有科學認知以及該項目的III期臨牀試驗結果，公司經綜合評估後，決定終止“粉塵蟎滴劑特應性皮炎適應症”項目。
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