Vera Therapeutics has announced final efficacy results from the Phase 3 ORIGIN 3 study of TRUTAKNA™ (atacicept-vymj), reporting sustained stabilization of kidney function and a reduced risk of kidney disease progression in adults with primary IgA nephropathy (IgAN). The final analysis included 428 patients with primary IgAN who were considered at risk of disease progression.
At 52 weeks, patients treated with TRUTAKNA experienced a mean change in estimated glomerular filtration rate (eGFR) of -0.1 mL/min/1.73 m², compared with -5.7 mL/min/1.73 m² among patients receiving placebo. This represented a placebo-adjusted treatment effect of 5.6 mL/min/1.73 m². At 104 weeks, the annualized decline in eGFR was -0.6 mL/min/1.73 m² per year with TRUTAKNA compared with -5.6 mL/min/1.73 m² per year with placebo, indicating a slower decline in kidney function in the TRUTAKNA group.
The study also demonstrated a reduction in the risk of kidney disease progression. Through 104 weeks, 11 patients receiving TRUTAKNA experienced a composite kidney disease progression event compared with 38 patients receiving placebo. Vera reported a hazard ratio of 0.24, corresponding to a 76% reduction in the relative risk of the composite endpoint. No patients in the TRUTAKNA group experienced dialysis lasting at least 30 days, kidney transplantation, or death during the 104-week period, while eight patients in the placebo group experienced one of these outcomes.
In addition to the kidney function findings, TRUTAKNA achieved statistically significant improvements in other prespecified measures, including proteinuria, galactose-deficient IgA1 (Gd-IgA1), and hematuria. According to Vera Therapeutics, the safety profile of TRUTAKNA remained generally favorable and comparable with placebo. Overall adverse events and infections or infestations were reported at similar rates between the treatment groups, with the company reporting no opportunistic infections or clinically relevant hypogammaglobulinemia.
TRUTAKNA, also known as atacicept-vymj, is a BAFF and APRIL inhibitor developed by Vera Therapeutics for the treatment of IgA nephropathy. The therapy targets two factors involved in B-cell activity and the production of immunoglobulins associated with IgA nephropathy. TRUTAKNA received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2026 for adults with primary IgA nephropathy who are at risk of disease progression. The approved regimen is a 150 mg subcutaneous injection administered once weekly.
Following the final ORIGIN 3 results, Vera Therapeutics said it plans to submit a supplemental Biologics License Application (sBLA) to the U.S. FDA during the fourth quarter of 2026. The submission is intended to support conversion of TRUTAKNA's accelerated approval to traditional approval. The company expects the potential regulatory decision in 2027.
The ORIGIN 3 findings provide longer-term clinical data on the ability of TRUTAKNA to slow the decline in kidney function in patients with IgA nephropathy. Vera Therapeutics said the detailed results from the final analysis will be presented at an upcoming scientific congress.
