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ARB-001467 · 1 trial · 1 indication
To evaluate the safety and tolerability of multiple doses of ARB-001467 in HBeAg-negative and HBeAg-positive subjects with chronic Hepatitis B virus infection who are receiving nucleos(t)ide analogue therapy
| Arm | Type | Description |
|---|---|---|
| 0.2 mg/kg ARB-001467 or Placebo | EXPERIMENTAL | HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.2 mg/kg versus placebo once a month for 3 months |
| 0.4 mg/kg ARB-001467 or Placebo | EXPERIMENTAL | HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months |
| ARB-001467 or Placebo | EXPERIMENTAL | HBeAg-positive subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months |
| 0.4 mg/kg ARB-001467 | EXPERIMENTAL | HBeAg-negative subjects receive ARB-001467 at. 0.4 mg/kg (open label) bi-weekly for 5 treatments and then subjects with HBsAg ≤1000 IU/mL AND ≥1.0 log10 decrease from baseline at Day 71 will continue monthly dosing through 48 weeks |
| Name | Type | Description |
|---|---|---|
| ARB-001467 | DRUG | An IV infusion of ARB-001467 |
| Placebo | OTHER | An IV infusion of placebo |
Key Inclusion Criteria: * Documented chronic HBV infection for ≥12 months prior to Screening Visit. * Quantitative HBsAg ≥1000 IU/mL at the Screening Visit. * Subjects currently receiving entecavir and/or tenofovir for ≥12 months and HBV DNA undetectable. Key Exclusion Criteria: * Known co-infect...
ARB-001467 is an investigational small molecule developed for the treatment of chronic hepatitis B virus infection. It was studied in patients already receiving nucleos(t)ide analogue therapy, a standard class of antiviral medicines used to suppress HBV. It is not an approved treatment and remains in clinical development.
ARB-001467 targets the hepatitis B virus itself. Its molecular target is HBV, placing it in the antiviral or virus-directed class of agents. By acting directly on the virus rather than on a human host protein, it aims to reduce viral activity in people with chronic hepatitis B infection.
ARB-001467 is being developed by Arbutus Biopharma Corporation, a biopharmaceutical company that trades under the ticker ABUS. Arbutus focuses on therapies for chronic hepatitis B and related viral diseases, and ARB-001467 is one of its HBV-directed small molecule candidates.
ARB-001467 has been studied in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 2 trial evaluating it has been completed, and no trials of this candidate are currently listed as active.
ARB-001467 was evaluated in one clinical trial, NCT02631096, titled Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy. That Phase 2 trial is completed and enrolled 36 participants across Australia and New Zealand. It was randomized and controlled, with participants aged 18 years and older.