李氏大藥廠(00950.HK)一款治療痤瘡藥物第III期試驗研究達到主要終點指標
格隆匯6月22日丨李氏大藥廠(00950.HK)公佈，公司附屬公司China Ophthalmology Focus Limited（COPFL）已成功完成於中國在其用於治療中度尋常型痤瘡的阿達帕林－克林黴素複方凝膠的關鍵第III期試驗。關鍵第III期試驗的主要數據表明該研究已達到主要終點指標，證明ACCG優於單獨使用阿達帕林凝膠或克林黴素凝膠，具有高度統計差異（P<0.0001）。預期將分別於2020年下半年及2021年提交新藥申請及取得銷售批准。
ACCG第III期多中心、隨機、單盲、平行、陽性對照研究（clinicaltrials.gov註冊編號：NCT03615768）旨在評估ACCG治療中度尋常型痤瘡的療效及安全性。先前第II期研究結果表明，0.1%阿達帕林+1%克林黴素乃治療尋常型痤瘡的最佳組合，並在該第III期研究中用作實驗組。該複方凝膠通過結合使用兩種具有不同作用機理的藥物及增加克林黴素的吸收來產生協同效應，從而減少使用抗生素以避免產生細菌耐藥性。
與兩個單獨分組相比，ACCG在主要終點指標方面有明顯改善，ACCG組的基線相對總病變計數的百分比變動為68.5%，而阿達帕林凝膠組及磷酸克林黴素凝膠組分別為52.8%（P<0.0001）及59.5%（P<0.0001）。
根據《中國痤瘡治療指南（2019修訂版）》，一項典型實例調查顯示，中國人羣尋常型痤瘡的發病率為8.1%，其中青少年患病率逾90%，並持續患病至成年。
據悉，阿達帕林－克林黴素複方凝膠乃COPFL一種用於治療中度尋常型痤瘡的在研專利產品。阿達帕林為一種視黃酸受體(RAR)激動劑，可刺激皮膚生長，而克林黴素為一種可阻斷細菌蛋白質合成的抗生素。阿達帕林及克林黴素具有不同的作用機制，目前已獲證明在尋常型痤瘡治療中，將兩種藥物結合使用的療效會較單獨使用更佳。
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