Mirum制药公司(MIRM)将停止对volixibat在ICP中的OHANA研究

凤凰网港股
Nov 29, 2022

Mirum制药公司(MIRM)宣布停止volixibat治疗妊娠肝内胆汁淤积症的OHANA研究,原因是纳入的可行性。ICP是妊娠期间胆汁淤积的一种情况,伴有瘙痒和胆汁酸水平升高,可导致胎儿并发症。在一项中期分析中,接受伏立西巴特治疗的患者血清胆汁酸和瘙痒症状明显减少。然而,由于在这种高风险怀孕的情况下注册面临挑战,Mirum决定停止OHANA,这使得公司可以优先考虑其他项目。Mirum正在继续推进LIVMARLI和volixibat有可能改变患者生活的适应症的广泛管道。即将到来的关键里程碑包括:LIVMARLI预计到2022年底,欧洲将批准用于两个月及以上Alagille综合征患者的胆汁淤积性瘙痒;LIVMARLI sNDA应用于进展性家族性肝内胆汁淤积症患者的瘙痒,预计2023年第一季度;PSC中的Volixibat中期分析,预计2023年中;Volixibat在PBC的中期分析,预计2023年下半年;肝胆闭锁的LIVMARLI 2b期数据预计2023年下半年;Mirum重申,2022年净产品营收预期为7000万美元,总营收预期为7200万美元,目前的资产负债表通过现金流正向运营支持增长。

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