Takeda disclosed that its investigational anti‑CD38 antibody, mezagitamab (TAK‑079), achieved a 55.2 % reduction in proteinuria and a 50.1 % decline in serum Gd‑IgA1 levels after 18 months of therapy, while estimated glomerular filtration rate remained stable with a mean change of +2.5 mL/min/1.73 m². Hematuria resolved in 60 % of the 30‑patient cohort, and no serious adverse events were reported during the 96‑week follow‑up.
The results reinforce the disease‑modifying potential of mezagitamab and provide a robust data set to support the company’s ongoing Phase 3 trials in IgA nephropathy and immune thrombocytopenia. A sustained proteinuria reduction and stable kidney function are key endpoints that regulators will scrutinize, and the safety profile observed in this early‑stage study strengthens the case for future regulatory submissions.
Takeda’s Q2 FY2025 earnings highlighted revenue and operating‑profit declines driven by Vyvanse generics and foreign‑exchange headwinds. The positive mezagitamab data offers a counterbalance, underscoring the value of the company’s rare‑disease pipeline and its strategic focus on high‑unmet‑need indications. Management has emphasized that the data support the company’s transition year strategy and its commitment to advancing therapies that address core disease mechanisms.
IgA nephropathy remains the most common primary glomerulonephritis and a leading cause of end‑stage kidney disease, yet approved disease‑modifying treatments are limited. Mezagitamab’s mechanism—targeting CD38‑expressing cells that produce aberrant Gd‑IgA1—addresses the underlying immune dysregulation, positioning it as a potentially transformative therapy in a market with significant unmet need.
The study’s safety profile, with no serious adverse events, aligns with the tolerability observed in other anti‑CD38 programs and supports the feasibility of larger, pivotal trials. The data also provide a benchmark for future efficacy comparisons as Takeda progresses through the clinical development pipeline.
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