Mirum announces primary endpoint met in Phase 2b portion of AZURE-1 study

Mirum Pharmaceuticals (MIRM) 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, for the treatment of chronic hepatitis delta virus. 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 arm and 75% of patients in the 900 mg once every four weeks arm achieved virologic response, as compared to 0% in the delayed treatment arm. Consistent with these antiviral effects, the primary composite endpoint of virologic response and alanine aminotransferase normalization was achieved in 45% and 35% of patients in the 300 mg QW and 900 mg Q4W arms, respectively, as compared to 0% of patients in the delayed treatment arm. After 24 weeks of treatment, further reductions in ALT and HDV RNA levels have been observed. These results support the potential of brelovitug as a single agent therapy to treat HDV. The efficacy results by treatment arm in the Phase 2b portion of AZURE-1 at Week 24 are presented below in Key Efficacy Endpoints.