Key Highlights:
- Takeda announced positive interim results from a Phase 3-enabling proof-of-concept study for mezagitamab (TAK-079) in patients with primary immunoglobulin A nephropathy (IgAN).
- Mezagitamab is a fully human, anti-CD38 IgG1 monoclonal antibody that depletes plasma cells, plasma blasts, and natural killer cells expressing CD38.
- At the American Society of Nephology (ASN) Kidney Week, Takeda showed mezagitamab as a favourable add-on therapy to standard of care for primary IgAN patients.
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Takeda Pharma announced positive interim results from a Phase 3-enabling proof-of-concept study for mezagitamab (TAK-079), an anti-CD83 monoclonal antibody, in patients with primary immunoglobulin A nephropathy (IgAN).
Globally, IgAN is the most prevalent form of primary glomerulonephritis and is associated with a poor prognosis, often leading to kidney failure, reduced quality of life or even premature death.
While three new treatments for IgAN have recently been approved in the US, unmet need remains for safe and effective medications for IgAN.
Mezagitamab is a fully human, anti-CD38 IgG1 monoclonal antibody that depletes plasma cells, plasma blasts, and natural killer cells expressing CD38. It is designed to deplete cells responsible for producing galactose-deficient IgA1 (Gd-IgA1) and autoantibodies against Gd-IgA1. Depletion of these cells is predicted to decrease formation of pathogenic Gd-IgA1 and IgA immune complexes, potentially reducing proteinuria and thus promoting stabilisation of renal function over time.
These positive results enable Takeda to discuss Phase 3 clinical development plans for mezagitamab in IgAN with global regulatory authorities. Takeda will also begin a Phase 3 trial of mezagitamab in primary immune thrombocytopenia (ITP) in fiscal year 2024.
The new data – presented at the American Society of Nephology (ASN) Kidney Week – showed:
- A favourable safety profile as an add-on therapy to standard of care for primary IgAN patients.
- No serious adverse events or discontinuations due to treatment-emergent adverse events (TEAEs).
- Rapid and sustained reductions in serum IgA, Gd-IgA1, and IgG from baseline levels.
- At 36 weeks, a 54.9% mean reduction in proteinuria (protein in the urine) – a validated marker for treatment impact on kidney function.
- Stable renal function maintained through 36 weeks.
IgAN is a lifelong progressive autoimmune disease often diagnosed in young people aged 10-30 years old that causes irreversible damage to kidney function. Despite current treatments, around one in five patients experience renal failure within a decade.