Mirum Phase 3 topline data for Brelovitug expected in Q3/Q4 2026
Topline results from the Ph2/3 AZURE-1 (N=200; PCD: May 2029) and Ph3 AZURE-4 trials (N=110; PCD: Aug 2026) CHD are now expected in Q3 and Q4 2026, respectively; previously guided to H2 2026
Mirum’s updated corporate presentation notes larger enrollment numbers for both trials than their current ct.gov listings (200 vs 150 for AZURE-1; 110 vs 80 for AZURE-4)
During the Q&A, it was asked if certain baseline patient characteristics from the Ph2b portion of AZURE-1 correlated with better efficacy responses; Mirum management noted no obvious features have been identified, with strong responses observed for patients irrespective of baseline viral RNA levels, ALT levels, and geography
Mirum noted its EMA registration-enabling Ph3 AZURE-2 (N=172; PCD: Jun 2027) and Ph2/3 AZURE-3 (N=120; PCD: Aug 2027) trials continue to enroll; Topline readout for both trials remains guided to H1 2028
Mirum continues to guide for H1 2027 BLA submission for brelovitug in CHD, with approval and launch expected in H2 2027
Mirum noted the Phase 2b portion of AZURE-1 met its primary endpoint, emphasizing the rapid and sustained reductions in HDV RNA and ALT achieved in this interim analysis
Brelovitug US IP coverage was reiterated to extend to 2041