arb-1476（Rnai）二期

newchinabok

http://www.arbutusbio.com/portfolio/arb-1467-rnai.php

newchinabok

ARB-1467 (formerly TKM-HBV) comprises three RNAi triggers that target all four HBV transcripts, and has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA and HBV DNA.  ARB-1467 utilizes Arbutus’ proprietary lipid nanoparticle (LNP) platform, a clinically validated delivery technology which has been tested in hundreds of patients.
Phase II ARB-1467 Multi-dosing Clinical Trial

The ARB-1467 Phase II clinical trial is a multi-dose study in chronic HBV patients who are also receiving stable nucleot(s)ide analog therapy. The trial consists of three cohorts, each enrolling eight subjects; six receiving three monthly doses of ARB-1467, and two receiving placebo. The first two cohorts include hepatitis B e-antigen (HBeAg) negative patients, followed by a third cohort in HBeAg positive patients. Single dose ARB-1467 results for Cohorts 1 and 2 demonstrate significant reductions in serum hepatitis B surface antigen (HBsAg) levels. Importantly, multiple dose results from Cohort 1 show a step-wise, additive reduction in serum HBsAg. These multiple dose results are the first of their kind for an RNAi product candidate in patients with chronic HBV infection. This trial is currently ongoing.

newchinabok

arb - 1467(原TKM-HBV)由三个RNAi触发目标四个HBV成绩单,和已被证明在临床前研究中减少所有病毒抗原以及cccDNA HBV DNA水平。arb - 1467利用杨梅自营脂质纳米粒(LNP)平台,临床验证交付技术已在数百名患者进行测试。
二期arb - 1467多剂量的临床试验
arb - 1467 II期临床试验是一种多剂量研究慢性乙肝病毒的患者也收到稳定nucleot(s)ide模拟治疗。试验包括三个军团,每个招收八个科目;接受三个月六个剂量的arb - 1467和两个接受安慰剂。前两个群体包括乙肝e-antigen(e抗原)阴性患者,紧随其后的是第三组e抗原阳性患者。单剂量arb - 1467组1和2的结果证明显著减少血清乙型肝炎表面抗原(HBsAg)水平。重要的是,多个剂量组1的结果显示步进式,添加剂降低血清表面。这些多个剂量结果是第一个同类的RNAi产品在慢性乙型肝炎病毒感染患者的候选人。这个试验目前正在进行。

newchinabok

https://clinicaltrials.gov/ct2/s ... =arbutus&rank=1