榮昌生物-B(09995.HK):泰它西普在中國治療重症肌無力(MG)的II期研究結果
格隆匯10月31日丨榮昌生物-B(09995.HK)宣佈,公司已完成了泰它西普(RC18,商品名:泰愛®)在中國治療重症肌無力(myasthenia gravis(MG))患者的II期研究,並獲得了相關數據結果。
本項研究為一項多中心、隨機、開放的臨牀研究,受試者為確診的、乙酰膽礆受體抗體陽性並接受穩定標準治療的全身型重症肌無力成人患者。該項研究共招募41例患者,隨機入組29例患者,其中14例患者使用泰它西普160mg劑量,15例患者使用240mg劑量,每週給藥一次,為期24周。研究主要療效終點為第24周QMG評分(重症肌無力評分(Quantitative Myasthenia
Gravis Score),是重症肌無力臨牀研究中最常用的量表之一)相比基線的變化。
研究結果顯示,泰它西普160mg劑量組患者的QMG評分平均降低7.7分,240mg劑量組患者的QMG評分平均降低9.6分,顯示出臨牀意義的顯著療效(QMG評分改善3分具有臨牀意義,改善5分以上有顯著療效),表明泰它西普能顯著改善全身型重症肌無力患者的病情,並體現出良好的安全性。目前,重症肌無力的主要治療方法包括膽礆酯酶抑制劑、糖皮質激素及免疫抑制劑,臨牀上尚存在大量未被滿足的臨牀需求。
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