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 (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 will 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.
Visit www.clinicaltrials.gov for additional information on this study.
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 www.ciscrp.org, 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.