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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 being developed for the treatment of chronic Hepatitis B. It is intended for patients with chronic HBV infection who are receiving nucleos(t)ide analogue therapy. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ARB-001467 is being developed by Arbutus Biopharma Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ABUS. The company is focused on developing therapies for infectious diseases, with a particular emphasis on Hepatitis B.
ARB-001467 is in Phase 2 clinical development. It has completed one Phase 2 trial, and no active trials are currently listed. The drug remains investigational and has not received regulatory approval for any indication.
ARB-001467 has been studied in a completed Phase 2 clinical trial with the identifier NCT02631096. This trial evaluated the drug in subjects with chronic HBV infection receiving nucleos(t)ide analogue therapy. The study enrolled 36 participants and was conducted in Australia and New Zealand.
No alternative names for ARB-001467 have been identified. The drug is known solely by its development code ARB-001467 and is being developed by Arbutus Biopharma Corporation.