Mirum Pharmaceuticals Announces Primary Endpoint Met in Phase 2b Portion of the AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Virus
Primary endpoint (virologic response and ALT normalization) achieved in both dose arms at Week 24
-Favorable safety and tolerability profiles observed
– Full results to be presented in a late-breaking poster presentation at EASL 2026
-Topline Phase 3 data from AZURE-1 and AZURE-4 expected in H2 2026
Excerpt from the Press Release:
FOSTER CITY, Calif.–(BUSINESS WIRE)–Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced the primary endpoint was met in the Phase 2b portion of the AZURE-1 study evaluating brelovitug, an investigational monoclonal antibody designed to bind hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus (HDV).
The Phase 2b portion of the AZURE-1 study included the first 53 patients evaluated at Week 24 of treatment.
At Week 24, treatment with brelovitug demonstrated robust antiviral activity across both dose groups. 100% of patients in the 300 mg once weekly (QW) arm and 75% of patients in the 900 mg once every four weeks (Q4W) arm achieved virologic response (≥2 log10 reduction in HDV RNA from baseline or undetectable HDV RNA [<LLOQ, TND]), as compared to 0% in the delayed treatment arm.
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