Assembly Biosciences, Inc. announced that the first subject has been dosed in the Phase 1a trial of its investigational core inhibitor ABI-4334 (4334). 4334 is an investigational next-generation core inhibitor that is optimized for significantly increased potency against covalently closed circular DNA (cccDNA) formation and new virus production versus first-generation core inhibitors. In preclinical research, 4334 has demonstrated sub-nanomolar potency against pgRNA encapsidation and 2-3 nanomolar potency against cccDNA formation.

Chronic HBV infection is a debilitating disease of the liver that is estimated to impact approximately 296 million people worldwide. HBV is the leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes. The Phase 1a clinical trial is a randomized, blinded and placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics of 4334 following single ascending dose and multiple ascending dose administration in healthy participants.

The objectives of the study include the proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results. Results of the trial will support dose selection for a future Phase 2 trial.