ALG-000184来自AASLD的后期断开1b期数据 KOL对新兴HBV疗法的展望

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https://investor.aligos.com/stat ... 2-807a-8257f76894f8

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Executive Summary
ALG-000184
• AASLD data show that daily oral dosing with 300 mg ALG-000184±ETV x ≤48
weeks in untreated HBeAg+ CHB pts results in:
– A favorable safety profile
– Greater suppression of HBV DNA and RNA vs. ETV alone (1st MOA)
– No viral breakthrough when ALG-000184 is given as monotherapy x ≤44 weeks
– Multi-log reductions in HBsAg, HBeAg, & HBcrAg, which appear to be mediated by
ALG-000184 (2nd MOA)
• ALG-000184 appears to lower cccDNA levels via 1st and 2nd MOA
• ALG-000184 may play an important role in enhancing rates of chronic
suppression (superior/non-inferior to NAs) and functional cure
• Next steps
– Continue ongoing ≤96 week cohorts
– Phase 2 enabling activities underway

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执行摘要

ALG-000184

•AASLD数据显示，每日口服300 mg ALG-000184±ETV x≤48

未经治疗的HBeAg+CHB患者的周数导致：

–良好的安全状况

–与单独使用ETV相比，对HBV DNA和RNA的抑制作用更强（第一次MOA）

–ALG-000184单药治疗x≤44周时无病毒突破

–HBsAg、HBeAg和HBcrAg的多对数减少，这似乎是由

ALG-000184（第二次MOA）

•ALG-000184似乎通过第一和第二MOA降低cccDNA水平

•ALG-000184可能在提高慢性

抑制（优于/不低于NAs）和功能性治疗

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接下来的步骤

–继续进行≤96周的队列

–正在准备的第二期临床试验，官宣过，明年。如果有二期，中国肯定有，一期在南方医院候金林教授那开展的