ARB-1467 (RNAi)

ARB-1467 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 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 2b ARB-1467 Clinical Trial Clinical Trial

The ARB-1467 Phase 2b clinical trial is a multi-dose study in chronic HBV patients who are also receiving stable nucleot(s)ide analog (NA) therapy. The trial consists of four cohorts, the first three enrolled eight patients; six receiving three monthly doses of ARB-1467, and two receiving placebo, and the fourth cohort enrolled twelve patients, all receiving five bi-weekly doses of ARB-1467. Cohorts 1, 2, and 4 enrolled hepatitis B e-antigen (HBeAg)-negative patients and Cohort 3 enrolled HBeAg-positive patients with AB-1467 administration at 0.2 mg/kg in Cohort 1 and 0.4 mg/kg in Cohorts 2, 3, and 4.


Results from this trial based on multiple dose administration of ARB-1467 in Cohorts 1, 2 and 3 demonstrated significant reductions in serum HBsAg levels and showed a step-wise, additive reduction in serum HBsAg with each subsequent dose. The HBsAg reduction achieved after three monthly doses of 0.4mg/kg in Cohort 2 was greater than that seen at 0.2 mg/kg in Cohort 1, demonstrating a dose-response seen with repeat dosing. In Cohort 4, five doses of ARB-1467 were administered on a bi-weekly dosing schedule and initial results demonstrated that all twelve patients had reductions in serum HBsAg levels with an average reduction of 1.4 log10 (maximum individual decline 2.7 log IU/mL), which was greater than that observed with monthly dosing in Cohorts 1-3.


New studies utilize bi-weekly dosing in a combination study of ARB-1467, with current standard of care NAs and interferon (IFN) therapies, to evaluate the opportunity to improve current cure rates with a finite dosing period. Combination treatment has the potential to result in sustained HBV DNA and HBsAg loss in patients. This trial is currently ongoing. 


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About Clinical Trials

 A clinical trial involves research using human volunteers (trial participants), and is intended to add to medical knowledge. Results can make a difference in the care of current and future patients by providing information about the benefits and risks of a potential drug. Visit, the Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.