Takeda(US:TAK) Businesswireยท2025-11-07 16:00Core Insights - Takeda has presented new data indicating that mezagitamab (TAK-079) shows sustained effects on kidney function in patients with primary IgA nephropathy, maintaining stable kidney function (eGFR) 18 months after the last treatment dose [1][2][4] Group 1: Clinical Study Results - In a Phase 1b open-label study, kidney function remained stable in patients with IgA nephropathy through Week 96, with a mean change in eGFR from baseline of +2.5 (95% CI: 1.8, +7.6; n=12) [4] - Patients experienced a 55.2% mean reduction in proteinuria (95% CI: 30.2, 72.6; n=13) and a 50.1% reduction in Gd-IgA1 levels by Week 96 [4][5] - Hematuria resolved in 60% of patients by Week 96, indicating significant improvements in kidney health [4] Group 2: Safety and Tolerability - Mezagitamab was generally well tolerated, with no serious adverse events, including serious hypersensitivity or injection-related reactions reported [5][6] - The study did not identify any new safety concerns, reinforcing the potential of mezagitamab as a treatment for autoimmune diseases like IgA nephropathy [5] Group 3: Future Development and Designations - Takeda is currently conducting pivotal Phase 3 clinical trials for mezagitamab in both primary IgA nephropathy and chronic immune thrombocytopenia, with patient enrollment ongoing [6] - Mezagitamab received Orphan Drug Designation from the European Medicines Agency for primary IgA nephropathy and Breakthrough Therapy Designation from the U.S. FDA for chronic immune thrombocytopenia [6]