- Phase 1b study shows stable eGFR in IgAN patients 18 months post-treatment with mezagitamab.
- Rapid reductions in proteinuria and serum Gd-IgA1 levels sustained through Week 96.
- No serious adverse events or opportunistic infections observed through Week 96.
- Phase 3 trials for mezagitamab in IgAN and immune thrombocytopenia are ongoing.
Study Overview
Takeda's Phase 1b open-label study of mezagitamab, an anti-CD38 monoclonal antibody, shows promising results in treating primary immunoglobulin A (IgA) nephropathy. Conducted over 96 weeks, the study indicates stable kidney function (eGFR) in patients up to 18 months after the last dose.
Key Findings
The study reports rapid reductions in proteinuria and serum Gd-IgA1 levels, sustained through Week 96. Importantly, no serious adverse events or opportunistic infections were observed during this period.
IgA Nephropathy Context
IgA nephropathy is a progressive autoimmune disease often diagnosed in individuals aged 10-30, leading to irreversible kidney damage. Despite existing treatments, about 20% of patients face renal failure within a decade of diagnosis. Mezagitamab targets early disease processes by depleting cells producing the abnormal protein Gd-IgA1, implicated in the disease's pathogenesis.
Future Directions
Takeda has initiated Phase 3 clinical trials to further evaluate mezagitamab's efficacy in primary IgA nephropathy and immune thrombocytopenia, with patient enrollment currently ongoing.
