Entrada Therapeutics Announced Preliminary Data From Its Phase 1 Trial For ENTR-601-44-101 In Healthy Volunteers, On Track To Submit Regulatory Applications In Q4 2024 To Initiate Separate Two Phase 2 Trials In Duchenne Muscular Dystrophy Patients
Entrada Therapeutics Announced Preliminary Data From Its Phase 1 Trial For ENTR-601-44-101 In Healthy Volunteers, On Track To Submit Regulatory Applications In Q4 2024 To Initiate Separate Two Phase 2 Trials In Duchenne Muscular Dystrophy Patients
Entrada Therapeutics宣佈其健康志願者EN TR-601-44-101的一期試驗的初步數據，計劃在2024年第四季度提交監管申請，以開展在DMD患者中進行分開的兩個二期試驗。
- ENTR-601-44 was well-tolerated in healthy volunteers with no serious adverse events, no drug-related adverse events and no clinically significant changes or trends noted in vital signs, ECGs, physical exams or laboratory assessments.
- ENTR-601-44 demonstrated significant plasma concentration, muscle concentration and exon skipping, at levels that suggest the potential for a clinically meaningful starting dose in planned upcoming patient trials.
- Phase 2 planning underway for separate ENTR-601-44 and ENTR-601-45 clinical trials with regulatory filings anticipated in Q4 2024
- ENTR-601-44在健康志願者中耐受良好，無嚴重不良事件、無藥物相關不良事件及無臨床意義的生命體徵、心電圖、體檢或實驗室檢查結果變化或趨勢。
- ENTR-601-44顯示了顯著的血漿濃度、肌肉濃度和外顯子跳躍水平，表明在計劃中即將進行的患者試驗中具有臨床意義的起始劑量潛力。
- 分別爲ENTR-601-44和ENTR-601-45進行第2階段規劃的臨床試驗，預計在2024年第4季度提交監管申請。