Mirum to Report Phase 3 AZURE-1 Topline Results for Brelovitug in Chronic Hepatitis Delta
核心洞察
Mirum Pharmaceuticals will host an investor call on September 28, 2026, to report topline results from the Phase 3 AZURE-1 study of brelovitug in chronic hepatitis delta virus (搜索).
AZURE-1 enrolled approximately 200 treatment-naive patients randomized 2:2:1 to brelovitug 300 mg weekly, 900 mg every four weeks, or a 24-week delayed therapeutic start.
The primary endpoint is a combined virologic and biochemical response measuring virologic response together with alanine aminotransferase normalization.
Mirum Pharmaceuticals will host an investor call on Monday, September 28, 2026, at 8:30 a.m. ET to report topline results from the Phase 3 AZURE-1 study of brelovitug in chronic hepatitis delta virus (搜索) (HDV), along with 48-week data from the Phase 2b portion of the study.
Chronic HDV is the most severe form of viral hepatitis and occurs in people already infected with hepatitis B virus (HBV). The disease can progress rapidly to liver fibrosis, cirrhosis, liver cancer, and liver-related death.
Trial Design and Endpoints
The global, registrational Phase 3 AZURE program comprises the AZURE-1 and AZURE-4 studies. Mirum completed enrollment in AZURE-1 in March 2026, with approximately 200 treatment-naive patients enrolled.
Participants were randomized in a 2:2:1 ratio to receive brelovitug 300 mg once weekly, 900 mg once every four weeks, or a 24-week delayed therapeutic start. The study's primary endpoint is a combined virologic and biochemical response, assessing virologic response together with alanine aminotransferase (ALT) normalization.
The company previously reported that the Phase 2b portion of AZURE-1 met its primary composite endpoint of virologic response and ALT normalization at Week 24 in both brelovitug dose groups compared with the delayed-treatment group.
Mechanism and Regulatory Status
Brelovitug is an investigational, fully human IgG1 monoclonal antibody designed to target the surface antigen of HDV and HBV. The drug is being developed to neutralize and remove viral particles and deplete surface-antigen-containing sub-viral particles. It has received FDA Breakthrough Therapy designation for chronic HDV infection.
Mirum expects the AZURE-1 and AZURE-4 studies to form the basis of a potential U.S. BLA submission for brelovitug.
Pipeline Context
Mirum is a rare disease company focused on rare liver and rare genetic diseases. Its commercial portfolio includes LIVMARLI (maralixibat) for Alagille syndrome (搜索) and progressive familial intrahepatic cholestasis (搜索), ATEBRIOZ (zilurgisertib) tablets for fibrodysplasia ossificans progressiva (搜索), CHOLBAM (cholic acid) for bile-acid synthesis disorders, and CTEXLI (chenodiol) for cerebrotendinous xanthomatosis (搜索).
The clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (搜索) and primary biliary cholangitis (搜索), brelovitug in late-stage development for chronic HDV, and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (搜索).
The September 28 call will be accessible by webcast through the Investors section of Mirum's corporate website, and an archived replay will be available.