Mirum Pharmaceuticals Provides AZURE Clinical Program Update for brelovitug in Chronic Hepatitis Delta Virus

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced completion of enrollment in the Phase 3 AZURE-1 study and completion of screening in the Phase 3 AZURE-4 study, both evaluating brelovitug for the treatment of chronic hepatitis delta virus (HDV). Achievement of these milestones confirms the expected timing of topline 24-week data in the second half of 2026. AZURE-1 and AZURE-4 together will form the basis of Mirum’s U.S. BLA submission for brelovitug, which has received Breakthrough Therapy designation from the FDA for the treatment of chronic HDV infection.

Brelovitug is being developed for HDV, the most severe form of viral hepatitis, and a disease with no approved therapies in the U.S. HDV occurs in people already infected with hepatitis B virus (HBV) and is associated with rapid progression to liver fibrosis, cirrhosis, liver cancer, and liver-related death.

“The completion of AZURE-1 enrollment and AZURE-4 screening represent important execution milestones as we advance brelovitug through the Phase 3 AZURE program,” said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. “We look forward to reporting interim data from AZURE-1 in the second quarter and topline results from AZURE-1 and AZURE-4 in the second half of 2026. Both studies are evaluating a composite endpoint of virologic response and ALT normalization at 24 weeks, aligned with FDA guidance for accelerated approval in HDV, and building on the strong antiviral activity observed in our Phase 2 study.”

“HDV is an aggressive disease that progresses quickly and leaves patients with very limited treatment options,” said Tatyana Kushner, M.D., MSCE, Associate Professor of Medicine, Division of Gastroenterology and Hepatology at Weill Cornell Medicine. “Having a well-tolerated single-agent therapy that achieves viral suppression and improves liver inflammation is critical for patients with HDV, and the progress of these Phase 3 studies brings us closer to potentially delivering a new therapy to patients in urgent need.”

Topline data from AZURE-1 and AZURE-4 are expected in 2H 2026, with a potential BLA submission and launch in the U.S. in 2027.

About Brelovitug

Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the chronic hepatitis delta virus (HDV) and the hepatitis B virus (HBV). Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles. Brelovitug has FDA Breakthrough Therapy designation for the treatment of chronic HDV infection and PRIME and Orphan designations from the European Medicines Agency. In the Phase 2 study, brelovitug demonstrated strong antiviral activity in HDV, achieving a 100% HDV RNA response, along with improvements in liver enzyme levels and a favorable safety profile, with the most common adverse event being injection-site erythema. Mirum owns worldwide rights to brelovitug.