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A promising new drug for a rare but serious liver infection just cleared a major hurdle. Mirum Pharmaceuticals announced that brelovitug, a monoclonal antibody targeting hepatitis delta virus (HDV), met its primary endpoint in a late-stage trial — with over half of patients in one dose group achieving meaningful viral suppression. An FDA marketing application is expected in the first half of 2027.
A rare liver disease may finally have a targeted treatment on the horizon. Mirum Pharmaceuticals announced that its experimental drug brelovitug successfully met the primary endpoint of a late-stage clinical trial for chronic hepatitis delta virus (HDV) — a severe liver infection that only strikes people already infected with hepatitis B. The disease can cause significant liver damage and death, and currently affects an estimated 230,000 people across the US and Europe.
Brelovitug is a monoclonal antibody that works by binding to the hepatitis B surface antigen, effectively targeting the virus at its surface. The drug was well tolerated across all dose groups, with a safety profile consistent with earlier data. Mirum plans to present full trial results at an upcoming medical congress and aims to file a marketing application with the FDA in the first half of 2027.
By the Numbers:
Why it matters: HDV is one of the most severe forms of viral hepatitis, yet treatment options remain extremely limited. If approved, brelovitug could become a much-needed targeted therapy for a population with few alternatives.