Mirum's Phase 3 Trial Shows Brelovitug Achieves Primary Endpoint in Hepatitis D Study

Mirum Pharmaceuticals reported that its phase 3 Azure-1 trial in chronic hepatitis delta met its primary efficacy goal, marking a significant step toward market entry in a field dominated by Gilead.

The study randomized patients to receive subcutaneous brelovitug either at 300 mg weekly or 900 mg every four weeks, while a control group delayed treatment for 24 weeks. Both dosing schedules outperformed the delayed‑treatment arm on the composite primary endpoint.

Analysts at Leerink Partners said the data position brelovitug as a commercially differentiated option in a nascent market that could expand as testing improves.

Overall, 56% of participants on the 300 mg regimen and 45% on the 900 mg regimen achieved the combined virologic response and ALT normalization, compared with none in the control group. Approximately 85% showed a virologic response, and ALT levels normalized in 63% and 54% of the two active arms respectively.