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
- 健康志願者對 ENTR-601-44 的耐受性良好，沒有嚴重的不良事件，沒有藥物相關的不良事件，生命體徵、心電圖、體格檢查或實驗室評估中沒有臨床顯著變化或趨勢。
- ENTR-601-44 顯示出顯著的血漿濃度、肌肉濃度和外顯子跳過，這些水平表明在計劃進行的患者試驗中有可能獲得具有臨床意義的起始劑量。
- 分開 ENTR-601-44 和 ENTR-601-45 臨床試驗的第 2 階段計劃正在進行中，預計將於 2024 年第四季度提交監管文件