Brelovitug - (AZURE)

September 28, 2026: Mirum Pharmaceuticals (NASDAQ: MIRM) reported that brelovitug met the primary endpoint in the Phase 3 portion of AZURE-1 for chronic hepatitis delta virus (HDV). At Week 24, the combined endpoint of virologic response plus ALT normalization was achieved by 56% of patients on 300 mg weekly SC and 45% on 900 mg every 4 weeks SC, versus 0% in the delayed-treatment arm (p<0.0001 for both). Virologic response rates were 86% and 85%; ALT normalization rates were 63% and 54%; HDV RNA target-not-detected rates were 17% in both active arms.

Safety through Week 24 was described as favorable and consistent with prior data, with no grade 3+ or serious adverse events in either brelovitug arm, no discontinuations, and injection-site reactions/flulike symptoms as the main treatment-related events.

In the Phase 2b portion of AZURE-1, 48-week data showed deeper viral suppression and higher ALT normalization versus Week 24. Combined response rose from 45% to 55% in the 300 mg weekly arm and from 35% to 55% in the 900 mg every-4-weeks arm; HDV RNA <10 IU/mL reached 80% and 40%, respectively.

Mirum said AZURE-4 Phase 3 topline results are expected in Q4 2026, with a planned BLA submission in H1 2027.