Clinical TrialApr 27, 2026, 08:12 AM
MIRM Brelovitug Phase 2b AZURE-1 Study Meets Primary Endpoint
AI Summary
Mirum Pharmaceuticals, Inc. announced that its investigational monoclonal antibody, brelovitug, met the primary endpoint in the Phase 2b portion of the AZURE-1 study for chronic hepatitis delta virus (HDV). At Week 24, the 300 mg once weekly arm showed a 100% virologic response, and the 900 mg once every four weeks arm showed a 75% response, significantly outperforming the delayed treatment arm. The drug was well tolerated, with further reductions in ALT and HDV RNA levels observed after 24 weeks. The company expects topline data from Phase 3 studies in H2 2026, with potential BLA submission and commercial launch in 2027.
Key Highlights
- Brelovitug Phase 2b AZURE-1 study met primary endpoint for chronic HDV treatment.
- 100% of patients in 300 mg QW arm achieved virologic response at Week 24.
- 75% of patients in 900 mg Q4W arm achieved virologic response at Week 24.
- Primary composite endpoint achieved in 45% (300 mg QW) and 35% (900 mg Q4W) of patients.
- Treatment with brelovitug was well tolerated across dose groups with no discontinuations.
- Full Phase 2b results to be presented at EASL Congress, May 27-30, 2026.
- Topline data from Phase 3 AZURE-1 and AZURE-4 studies expected in H2 2026.
- Potential BLA submission and U.S. commercial launch anticipated in 2027.