Brelovitug Achieves Primary Efficacy Goals in Late-Stage Hepatitis D Study

Brelovitug, a monoclonal antibody targeting hepatitis B surface antigen, successfully met its primary endpoint in the Phase 3 AZURE-1 trial for chronic hepatitis D infection, with 56% of patients on weekly dosing achieving combined virologic and liver enzyme normalization at week 24. The response rate was significantly higher than the control group, which showed zero percent response. The manufacturer plans to submit a biologics license application in early 2027 with a potential U.S. market launch by late 2027.

Hepatitis D, also known as HDV, is a serious liver infection that occurs only in people already infected with hepatitis B. The condition represents a significant clinical challenge because it compounds the existing damage caused by hepatitis B alone. Brelovitug addresses this dual infection by targeting hepatitis B surface antigen, a key protein on the virus's outer layer that both hepatitis B and D viruses require for survival and transmission.

The AZURE-1 trial compared two different dosing schedules of the drug against a control group receiving delayed treatment. The weekly 300-milligram dose proved slightly more effective than the less-frequent 900-milligram regimen, with both substantially outperforming the control approach. The primary measure of success combined evidence of viral suppression with normalization of alanine aminotransferase, a liver enzyme whose elevation signals hepatic damage.