Mirum says Phase 3 AZURE-1 trial meets primary endpoint for brelovitug in chronic hepatitis delta virus
MIRM•Mirum said its Phase 3 AZURE-1 trial met its primary endpoint at Week 24, with brelovitug improving viral control and liver inflammation versus delayed treatment. The company plans a U.S. BLA submission in H1 2027 and is targeting a potential launch in Q4 2027.
1. Phase 3 results
Mirum said its Phase 3 AZURE-1 trial met its primary endpoint for brelovitug in chronic hepatitis delta at Week 24. Results showed improved viral control and liver inflammation versus delayed treatment, supporting the drug’s potential as a single-agent therapy.
2. Next milestones
Longer-term Phase 2b data through Week 48 showed responses continued to strengthen with extended dosing. Full Phase 3 results will be presented at a future medical congress; AZURE-4 topline data are expected in Q4 2026. Mirum is planning a U.S. BLA submission in H1 2027 and targeting a potential U.S. launch in Q4 2027.
