Hepatitis B: Updates from Aligos Therapeutics, Arbutus Biopharma Corporation and Precision BioSciences

Aligos Therapeutics announces first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection and grant of FDA Fast Track Designation

Aligos Therapeutics announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection for the Part 2a (HBeAg- cohort) where the independent Data Safety Monitoring Review Board has recommended continuation of the study with an increase in sample size for this cohort in order to optimize statistical powering; futility criteria for the cohort was not met. Additionally, Aligos announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to pevifoscorvir sodium, a potential best/first-in-class capsid assembly modulator (CAM-E) under investigation for the treatment of chronic hepatitis B virus infection.

Arbutus receives US FDA Fast Track Designation for imdusiran for the treatment of chronic hepatitis B

Arbutus Biopharma Corporation announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for imdusiran for the treatment of chronic hepatitis B. Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens, including hepatitis B surface antigen (HBsAg), which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine delivery technology enabling subcutaneous delivery.

Precision BioSciences expands ELIMINATE-B trial following clinical trial application approval in two European countries

Precision BioSciences announced that it has received Clinical Trial Application approval to expand the ongoing global ELIMINATE-B clinical trial of PBGENE-HBV. The regulatory authorization will allow Precision to initiate important hepatitis B clinical trial sites in France and Romania. This expansion broadens the trial’s global footprint deeper into Europe, adding to existing clinical trial sites in the United Kingdom, Moldova, New Zealand, Hong Kong and the United States.