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宣布其健康志愿者EN TR-601-44-101的一期试验的初步数据，计划在2024年第四季度提交监管申请，以开展在DMD患者中进行分开的两个二期试验。
- 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在健康志愿者中耐受良好，无严重不良事件、无药物相关不良事件及无临床意义的生命体征、心电图、体检或实验室检查结果变化或趋势。
- ENTR-601-44显示了显著的血浆浓度、肌肉浓度和外显子跳跃水平，表明在计划中即将进行的患者试验中具有临床意义的起始剂量潜力。
- 分别为ENTR-601-44和ENTR-601-45进行第2阶段规划的临床试验，预计在2024年第4季度提交监管申请。