Mirum Pharmaceuticals Announces Primary Endpoint Met in Phase 2b Portion of the AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Virus
Mirum Pharmaceuticals reported positive Phase 2b data from the AZURE-1 study, where Brelovitug met its primary composite endpoint of virologic response and ALT normalization in patients with chronic hepatitis delta virus. Treatment demonstrated robust antiviral activity with 100% of patients in the 300 mg arm achieving virologic response at Week 24, compared to 0% in the delayed treatment arm, and safety was favorable across both dose groups. Topline Phase 3 data from the AZURE-1 and AZURE-4 studies are expected in the second half of 2026, with potential BLA submission and U.S.
Key figures
- Drug Name
- Brelovitug
- Phase Of Trial
- Phase 2b
- P value 300mg
- 0.003
- P value 900mg
- 0.024
- Phase3 timing
- H2 2026
- Vr 300mg qw percent
- 100%
- Vr 900mg q4w percent
- 75%
- Primary endpoint 300mg percent
- 45%
- Primary endpoint 900mg percent
- 35%
- Alt normalization 300mg percent
- 45%
- Primary endpoint delayed percent
- 0%
AI analysis
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