French-based biotech company Abivax announces results of Phase IIb/III trial (ABX203-002) of ABX203 to treat patients afflicted with chronic hepatitis B (CHB).
ABX203 is Abivax's therapeutic vaccine candidate that can control the virus load for a longer duration with a treatment period shorter than the current standard of care.
The open-label, randomised and comparative ABX203-002 trial is intended to evaluate the efficacy of ABX203 to control hepatitis B virus for a longer duration after cessation of nucleotide analogs (NUCs).
The trial has enrolled 276 subjects categorised into two groups, where one group was administered with ABX203 for 24 weeks with the current standard care, nucleoside analogues, NUCs.
The therapy was stopped after 24 weeks, after which the patients were tested against a control group only subjected to NUCs.
The Data Safety and Monitoring Board (DSMB) of study ABX203-002 has given recognition of its safety profile and has agreed on the study's further procedure of monitoring the patients for 24 weeks post-treatment for a continued assessment of their viral load.
However, an unscheduled futility analysis conducted due to patients' drop out rate owing to viral escape has declared the improbability of the study to achieve a positive outcome.
A previous differently designed Phase II study of ABX203 was conducted in Asia and had involved patients without any prior related treatment who were administered with ABX203 as monotherapy.
The result exhibited a longer duration of viral rebound in patients as compared with patients receiving Peg-Interferon Alpha.