Mirum’s Brelovitug Hits Phase 3 Primary Endpoint in Hepatitis Delta
- The Phase 3 portion of AZURE-1 met its primary endpoint at week 24: roughly half of treated patients responded on either the weekly or four-weekly subcutaneous regimen, versus none on delayed treatment.
- No grade 3 or higher or serious adverse events were reported through week 24. A second Phase 3, AZURE-4, is expected in Q4, with a filing possible in the first half of next year.
💡 Points
Mirum now has a credible, differentiated challenger in hepatitis delta, with a monthly-dosing option that Gilead's and Vir's programs will have to answer commercially. But the depth-of-suppression numbers are modest, so the AZURE-4 readout matters more than today's headline. For an acquired asset, a clean first Phase 3 also validates the deal thesis and de-risks Mirum's rare-liver pipeline story.
Mirum posts phase 3 hepatitis win for 'commercially different… ↗