Vera Therapeutics, Inc. announced on September 15, 2026, that TRUTAKNA (atacicept-vymj) met all prespecified endpoints of the final efficacy analysis for the ORIGIN 3 trial. The trial focused on adults with primary IgA nephropathy (IgAN) who are at risk for disease progression.
The final analysis included a set of 428 patients. The data indicates that TRUTAKNA stabilized estimated glomerular filtration rate (eGFR). At 52 weeks, the mean eGFR change from baseline was -0.1 mL/min/1.73m² for TRUTAKNA, compared to -5.7 mL/min/1.73m² for placebo. The treatment effect was 5.6 mL/min/1.73m² with a p-value of less than 0.0001. Over 104 weeks, the annualized eGFR slope for TRUTAKNA was -0.6 mL/min/1.73m²/year, compared to -5.6 mL/min/1.73m²/year for placebo.
TRUTAKNA also demonstrated a 76% risk reduction in composite kidney disease progression events through 104 weeks. In this composite endpoint, which includes dialysis lasting 30 days or more, kidney transplantation, or death, there were 11 events in the TRUTAKNA group and 38 in the placebo group. The hazard ratio was 0.24.
Additionally, the company reported that TRUTAKNA achieved statistically significant reductions in proteinuria, galactose-deficient IgA1 (Gd-IgA1), and hematuria. The safety profile was described as favorable and generally comparable to placebo. Rates of overall adverse events and infections were similar between the two groups, with no opportunistic infections or clinically relevant hypogammaglobulinemia reported.
The company stated that it plans to submit a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for full approval in the fourth quarter of 2026. The company also noted strong commercial momentum, having generated over 350 patient start forms in the first ten weeks since launch.
