FDA解除Kezar Life Sciences Zetomipzomib自身免疫性肝炎2a期试验部分临床保留

华尔街洞察
Jul 16

Kezar Life Sciences Inc.宣布,美国食品药品监督管理局(FDA)已解除对其PORTOLA 2a期试验的部分临床保留。这项试验旨在评估首创选择性免疫蛋白酶体抑制剂zetomipzomib用于治疗自身免疫性肝炎(AIH)的疗效与安全性。FDA的决定基于对zetomipzomib项目全面的安全性评估结果。

公司首席执行官Chris Kirk表达了对该药物潜力的乐观预期,认为其可能为AIH患者带来积极影响。他同时透露,将就后续临床试验设计与FDA展开深入讨论。尽管狼疮肾炎(LN)领域的开发已暂停,以集中资源于AIH适应症,但Kezar计划依据独立数据监测委员会的建议,寻求解除zetomipzomib在LN领域的临床保留。

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