Overview

• The 100-week ADU-CL-19 Phase 1/2 study in 40 biopsy-confirmed IgAN patients achieved a 60 percent median proteinuria reduction at week 100, with 55 percent of participants below 500 mg/24 h and 31 percent below 300 mg/24 h.
• Estimated glomerular filtration rate remained stable across all patient subgroups throughout the treatment period, indicating sustained renal function.
• Serological analyses showed a 74 percent drop in total IgA and galactose-deficient IgA1, confirming APRIL pathway inhibition as zigakibart’s mechanism of action.
• Zigakibart was well tolerated over 100 weeks, with most adverse events rated mild to moderate and no treatment-related serious infections or discontinuations reported.
• The global Phase 3 BEYOND trial is now enrolling a broader IgAN population with primary proteinuria endpoints at 40 weeks and kidney function follow-up through 104 weeks, alongside an open-label extension study.