Arbutus and Assembly Bio to combine RNAi therapy with core inhibitor for potential HBV cure

CAR-T Digest - August 2020

27 Aug 2020

AB-729 (RNAi targeting HBV antigen) – Arbutus Biopharma; ABI-H0731 (core inhibitor) – Assembly Biosciences

Arbutus Biopharma and Assembly Biosciences will initiate a randomized, multi-center, open-label Phase 2 clinical trial to explore the safety, pharmacokinetics, and efficacy of the triple combination: AB-729+ ABI-H0731) + nucleos(t)ide reverse transcriptase inhibitor (NRTI e.g., Entecavir, tenofovir) Vs the double combinations: ABI-H0731 + NrtI and AB-729 + NrtI
N= 60 virologically-suppressed patients with HBeAg negative or positive chronic HBV infection
Dosing frequency – ABI-H0731 300mg QD, AB-729 (dose not disclosed) for 48 weeks with 24 week follow up
As part of the collaboration, Other patient types and/or combinations may be added as cohorts later – Trial initiation expected in H1’21

CI Scientists Remarks:

Technology – Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology enables subcutaneous delivery
AB-729 (RNAi based therapy) has shown positive interim results in chronic HBV patients in phase 1a/1b trial (ongoing first-in-human clinical trial) (ACTRN12619001197123)
Dosing: In Phase 1a/1b results, AB-729 showed positive results for 60 mg and 180 mg dose level; Currently evaluating 90 mg dose in chronic HBV subjects with results expected in H2’20. Based on the results Arbutus will decide the dosing for the phase 2 combination trial
ABI-H0731 has shown positive clinical data in NrtI-suppressed patients, NrtI-naive patients both alone and in combination with NrtI therapy compared to NrtI alone
A combination regimen of AB-729 and ABI-H0731 could be a potent treatment option for all segments of HBV patients

– Tarun Raisinghani, CI Scientists

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