Arbutus is gearing up to present preliminary safety and antiviral activity of AB-729 combination treatment in virally suppressed, HBeAg-negative subjects with chronic HBV (cHBV) infection at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna.
The company has reported Phase 1a/1B and IIa results from the randomised, open-label, multicentre trial (NCT04980482).
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By GlobalDataThe study is investigating the safety and antiviral activity of AB-729, an RNA interference (RNAi) therapeutic, in combination with ongoing nucleos(t)ide analogue (NA) therapy and short courses of pegylated interferon alfa-2a (Peg-IFNα-2a) in subjects with cHBV.
AB-729 treatment in virally suppressed cHBV patients was well tolerated and led to mean HBsAg declines of more than 1.6 log10 after 24 weeks of treatment. HBsAg levels less than 100 IU/mL were noted in 88% of the subjects.
According to the Canadian company, this interim data analysis suggests addition of IFN was well tolerated, and AB-729 + IFN appears to result in continued HBsAg declines in most subjects with 2 subjects reaching HBsAg <LLOQ during IFN treatment.
AB-729 was generally safe and well-tolerated after completing dosing in 41 patients.
Data from the Phase IIa clinical trial evaluating AB-729 in combination with Vaccitech’s immunotherapeutic, VTP-300, and a NA is expected to be reported in the latter half of 2023.
Other drugs in Arbutus’ HBV pipeline are Phase I AB-161, and pre-clinical AB-101.
According to GlobalData, the HBV market is dominated by NA for the long-term treatment of cHBV, most of which are available as generic versions, while pegylated interferon therapy only holds a market share of 13.1 percent.
The current standard of care for HBV is Gilead Science’s Vemlidy (tenofovir alafenamide). However, GD forecasts a decline in Vemlidy’s sales from $852 million on 2022 to $643 million in 2029.
GlobalData is the parent company of Clinical Trials Arena.
Recent advancement in HBV therapies include Bluejay therapeutics’s monoclonal antibody.
