口服类固醇Nefecon治疗原发性IgA肾病,达到III期关键临床终点

2020-11-09 MedSci原创 MedSci原创

Calliditas Therapeutics是目前唯一一家在原发性IgA肾病的III期临床试验中获得阳性结果的公司。

Calliditas Therapeutics宣布其口服类固醇Nefecon(budesonide)治疗原发性IgA肾病患者的III期研究达到主要终点,该公司股价周一上涨了42%。

tm2019773-4_424b4 - none - 17.100468s

图片来源:https://www.sec.gov/Archives/edgar/data/1795579/000110465920070680/tm2019773-4_424b4.htm

根据Calliditas的说法,该研究的A部分达到了其主要目标,即与安慰剂相比,用Nefecon治疗9个月后尿蛋白肌酐比率(UPCR)显着降低,并在12个月时持续显着改善。Nefecon治疗后患者的UPCR与基准相比平均降低31%,而安慰剂平均降低5%,与安慰剂相比,在9个月时平均降低27%。

该试验也达到了关键的次要终点,与安慰剂相比,Nefecon治疗9个月后肾小球滤过率(eGFR)存在显着差异。结果发现,接受Nefecon治疗患者的eGFR稳定,而安慰剂组下降了7%。

Calliditas Therapeutics是目前唯一一家在原发性IgA肾病的III期临床试验中获得阳性结果的公司。

原始出处:

https://www.firstwordpharma.com/node/1772101?tsid=4

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    2021-06-09 juliusluan78
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    2020-11-11 yibei
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