Atacicept-vymj delivers strong 2-year results for IgA nephropathy, paving the way for full FDA approval

A kidney disease drug just aced its biggest test yet. The phase 3 ORIGIN 3 trial of atacicept-vymj (Trutakna, Vera Therapeutics) met all prespecified endpoints over two years in adults with IgA nephropathy (IgAN) — a chronic autoimmune kidney disease with limited treatment options. Presented at ASN Kidney Week and simultaneously published in The New England Journal of Medicine, the results reinforce the drug's potential as a disease-modifying therapy.

In the double-blind, randomized trial of 428 adults, atacicept-vymj — a B-cell-directed therapy given as a weekly 150 mg injection — significantly outperformed placebo across every measured outcome, from kidney filtration rates to urinary protein levels. Notably, no patients on atacicept-vymj progressed to dialysis, transplantation, or death, compared to seven in the placebo group (including one death). Adverse events were mostly mild to moderate.

By the Numbers:

• +5.58 mL/min/1.73 m² — difference in eGFR change from baseline at week 52 (atacicept-vymj vs. placebo)
• 5 mL/min/1.73 m² per year — difference in annualized eGFR slope through week 104
• 51% — reduction in 24-hour urinary protein-to-creatinine ratio vs. placebo
• 67% — reduction in serum galactose-deficient IgA1 levels vs. placebo
• 80.9% vs. 21.4% — hematuria resolution rates (atacicept-vymj vs. placebo)
• 76% lower risk of composite kidney disease progression (HR = 0.24)

Why it matters: IgAN can silently destroy kidney function over years, and effective therapies have historically been scarce. With full FDA approval now being pursued, atacicept-vymj could soon become a go-to option for nephrologists managing high-risk IgAN patients worldwide.