Assembly Bio公司 EASL 2019 Review PDF - 学术讨论& HBV English

EASL Highlights and Next Steps
• Nucs are effective, but do not eliminate residual HBV DNA and HBV RNA
• Combination of 731+ Nuc demonstrated potential to eliminate residual HBV DNA
• Core Inhibitors have the potential to be the backbone of future HBV regimens
– We believe that elimination of residual viremia will likely be a critical milestone required to increase
rates of cure
• 2158 currently in dose finding Phase 1b study and Phase 2a studies expected to follow
immediately
• 3733 expected to initiate Phase 1a study in early 2020
• Initiating discussions with global regulatory bodies regarding design of next studies and
pathways to approval for 731 + Nuc combination

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newchinabok

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发表于 2019-4-15 21:57 |只看该作者

EASL亮点和下一步
•nucs是有效的，但不能消除残留的HBV DNA和HBV RNA。
•结合731+nuc可消除残留的HBV DNA。
•核心抑制剂有潜力成为未来HBV治疗方案的支柱。
–我们认为，消除残余病毒血症可能是增加
治愈率
•2158目前正在进行剂量发现阶段1b研究和阶段2a研究，预计随后
立即
•3733预计将于2020年初启动第1a阶段研究。
•开始与全球监管机构讨论下一项研究的设计，以及
731+NUC组合的批准途径

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newchinabok

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发表于 2019-4-15 22:12 |只看该作者

本帖最后由 newchinabok 于 2019-4-15 22:13 编辑

Initiating discussions with global regulatory bodies regarding design of next studies and
pathways to approval for 731 + Nuc combination与全球监管机构就731+Nuc组合的下一项研究和批准途径的设计展开讨论。（个人认为fda快速通道上市）

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