FSGS的DMX-200行动3试验成功招收了21个国家的286名病人,显示出减少蛋白质尿症的早期前景。
The ACTION3 trial for DMX-200 in FSGS successfully enrolled 286 patients across 21 countries, showing early promise in reducing proteinuria.
Dimerix主导的第3阶段行动3在焦点分区球球硬化(FSGS)对DMX-200进行的DMX-200试验已成功地登记并实现了目标,在21个国家,包括美国、欧洲、日本和亚洲部分地区,有286名病人接受了治疗。
The Dimerix-led Phase 3 ACTION3 trial for DMX-200 in focal segmental glomerulosclerosis (FSGS) has successfully enrolled and dosed its target 286 patients across 21 countries, including the U.S., Europe, Japan, and parts of Asia.
该多中、双盲、安慰剂控制的研究对DMX-200以及两年来标准的血管二型受体阻塞疗法进行了评价,重点是蛋白质减少和肾功能。
The multi-center, double-blind, placebo-controlled study evaluates DMX-200 combined with standard angiotensin II receptor blocker therapy over two years, focusing on proteinuria reduction and kidney function.
在这些剂量中,69个已经完成治疗,65个加入开放标签扩展。
Of those dosed, 69 have completed treatment, with 65 joining an open-label extension.
审判通过了7次独立的安全审查,没有出现任何问题。
The trial has passed seven independent safety reviews without issues.
首批72名病人的早期结果显示蛋白质减少,DMX-200比安慰剂的蛋白质减少。
Early results from the first 72 patients showed reduced proteinuria with DMX-200 versus placebo.
在盲目分析之前,Dimerix和Amicus Therapeutics计划寻求FDA对终点的反,以期获得潜在的监管批准.
Dimerix and Amicus Therapeutics plan to seek FDA feedback on endpoints before a blinded analysis, aiming for potential regulatory approval.