AB-729-203
Research type
Research Study
Full title
A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination with Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects with Chronic HBV Infection
IRAS ID
1009289
Contact name
Lester Gibbs
Contact email
Sponsor organisation
Arbutus Biopharma Corporation
Research summary
This study is called AB-729-203 and it is a Phase 2 study, meaning this is an early study of the safety and efficacy of the investigational drug imdusiran as part of a new treatment combination. It is being tested in a small number of participants with chronic (long-lasting) hepatitis B infection (CHB) who are already taking medications called nucleoside analogues (NA) [includes tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), or entecavir (ETV)] to control their CHB. An investigational drug is one that is not approved for sale in any country. Participants have to have been taking their NA treatment for at least 6 months such that their levels of hepatitis B virus (HBV) DNA are suppressed so low that the HBV DNA cannot be measured in their blood.
This study will examine if giving 2 doses of low dose durvalumab along with imdusiran can increase the likelihood of subjects reaching very low levels of hepatitis B surface antigen (HBsAg), a marker of CHB disease activity.
Subjects with very low HBsAg may have a better chance of achieving a “functional cure” (functional cure is defined as having no detectable HBV DNA and no detectable HBsAg for at least 6 months after stopping all HBV treatment). If patients’ HBV markers reach these low levels after the treatment period with imdusiran and durvalumab is over, they will stop their regular CHB treatment (ETV, TDF, or TAF) and they will be followed closely to see if they have achieved functional cure.
The investigational medicines that are being added to ongoing NA treatment in this study are imdusiran to help attack HBV directly, and durvalumab, a medicine already approved for some types of cancers that helps boost the immune system, in this case to fight the HBV infection.REC name
Wales REC 3
REC reference
24/WA/0012
Date of REC Opinion
15 Mar 2024
REC opinion
Further Information Favourable Opinion