– Phase 3 primary endpoint (virologic response and ALT normalization) achieved in both dose arms at Week 24

– 48-week data from Phase 2b portion of AZURE-1 demonstrate deepening viral suppression and increased rates of ALT normalization with longer-term treatment

– Favorable safety and tolerability profiles observed; no new safety signals

– Mirum to host conference call to discuss topline results today, September 28, at 8:30 a.m. ET

Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a leading rare disease company, today announced the primary endpoint was met in the Phase 3 portion of the AZURE-1 study evaluating brelovitug, an investigational fully human monoclonal antibody that binds to hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus (HDV). In addition, 48-week data from the Phase 2b portion of AZURE-1 demonstrated deepening viral suppression, with a greater proportion of patients achieving HDV RNA below the lower limit of quantification (LLOQ, <10 IU/mL) and target not detected (TND), and increased rates of alanine aminotransferase (ALT) normalization. AZURE-1 is one of two pivotal Phase 3 studies intended to form the basis of Mirum’s U.S. registration package for brelovitug.