騰盛博藥(02137.HK)遭美國要求暫停BRII-732一期臨牀研究
騰盛博藥-B(02137.HK)公佈,已收到美國食品藥品監督管理局(FDA)通知,要求公司暫停在健康受試者中評估BRII-732安全性的一期臨牀研究。
由於FDA決定暫時暫停基於islatravir相關的臨牀研究,因此作爲此決定的一部分,BRII-732的一期臨牀研究將暫停。islatravir是默沙東(MRK.US)正在開發的候選藥物,BRII-732是公司開發的islatravir的一種專利前藥,在被要求暫停之前未觀察到任何嚴重的安全信號。
騰盛博藥副總裁、感染性疾病治療負責人David Margolis表示,暫停臨牀並非因研究中觀察到的任何信號所引起,也不是基於BRII-732的臨牀前數據,患者安全至關重要,鑑於FDA採取預防措施暫停涉及islatravir的臨牀研究並進行進一步調查研究這一決定,公司將與FDA密切合作,全力配合調查,並進一步討論BRII-732的開發策略。
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