盟科藥業(688373.SH):成功完成注射用MRX-4中國Ⅲ期臨牀試驗
格隆匯11月27日丨盟科藥業(688373.SH)公佈,公司開展的注射用MRX-4轉口服康替唑胺片治療複雜性皮膚和軟組織感染成人患者的中國Ⅲ期臨牀試驗已於近日成功完成並達到了主要療效終點。公司將積極推進注射用MRX-4治療複雜性皮膚和軟組織感染適應症在中國的新藥申報上市進程。
本研究結果表明,當靜脈輸注MRX-4首劑2000mg,餘1000mg(後續可轉口服康替唑胺片800mg,此給藥方式簡稱“MRX-4/康替唑胺片”),每12小時給藥一次,療程7-14天治療複雜性皮膚和軟組織感染患者(包括耐甲氧西林金黃色葡萄球菌(MRSA)所致者),具有良好的臨牀療效和微生物學療效。統計學分析顯示MRX-4/康替唑胺片治療複雜性皮膚和軟組織感染的臨牀療效非劣效於利奈唑胺組,本研究達到主要療效終點。本研究安全性觀察結果顯示,注射用MRX-4/康替唑胺片治療複雜性皮膚和軟組織感染,患者安全性和耐受性良好。在本研究中,未發生與研究藥物相關的導致中止治療或退出研究不良事件。接受注射用MRX-4/康替唑胺片患者發生與研究藥物相關的臨牀不良事件主要為胃腸道反應,包括噁心、嘔吐等,與研究藥物相關的實驗室檢查異常主要為肝酶輕度升高,多為輕度,且呈一過性。在目前的給藥方案下,注射用MRX-4/康替唑胺片組患者出現血小板降低趨勢以及與研究藥物相關的血液學不良事件明顯少於利奈唑胺組。
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