Mirum Pharmaceuticals Announces Primary Endpoint Met in Phase 3 AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Virus
Mirum Pharmaceuticals reported that brelovitug met the Phase 3 AZURE-1 primary endpoint in chronic hepatitis delta, with 56% (300 mg QW) and 45% (900 mg Q4W) of patients achieving combined virologic response and ALT normalization at Week 24 versus 0% in the delayed treatment arm (p<0.0001 for both). Forty-eight-week Phase 2b data showed deepening viral suppression, with HDV RNA below the limit of quantification rising to 80% (300 mg QW) and 40% (900 mg Q4W), and the primary endpoint reaching 55% in both arms. Safety was favorable with no new signals and zero treatment discontinuations in Phase 3 through Week 24. AZURE-1 is one of two pivotal studies supporting the U.S.
Key figures
- Drug Name
- brelovitug
- Phase Of Trial
- Phase 3
- P value
- <0.0001
- Azure4 topline
- Q4 2026
- Bla submission
- H1 2027
- Phase3 enrolled
- 153
- Potential us launch
- Q4 2027
- Week48 primary endpoint phase2b
- 55% both arms
- Phase3 primary endpoint 300mg qw
- 56%
- Phase3 primary endpoint 900mg q4w
- 45%
- Delayed treatment arm primary endpoint
- 0%
AI analysis
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