Vera Therapeutics (Nasdaq: VERA) announced that the final efficacy analysis of its ORIGIN 3 trial for TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy (IgAN) met statistical significance across all prespecified endpoints. The results were presented at the American Society of Nephrology Kidney Week 2026 and simultaneously published in the New England Journal of Medicine.

The trial, which enrolled 428 patients split evenly between TRUTAKNA and placebo groups, achieved its primary endpoint of statistically significant proteinuria reduction at 36 weeks. Additional endpoints showing statistical significance included estimated glomerular filtration rate (eGFR) change from baseline, annualized eGFR slope, and a composite measure of kidney disease progression events. The drug also produced statistically significant reductions in urine-protein to creatinine ratio, galactose-deficient IgA1, and hematuria.

Adverse events were reported in 75% of patients in the TRUTAKNA group compared with 78% in the placebo group. Serious adverse events occurred in 7% of patients on TRUTAKNA versus 15% on placebo. Infection rates were similar between the two groups at 51.4% and 52.3%, respectively. One death was recorded in the placebo group and none in the TRUTAKNA group.

TRUTAKNA received accelerated FDA approval based on proteinuria reduction. The agency has not established whether the drug slows long-term kidney function decline, and continued approval may depend on confirmatory trial results.

Vera Therapeutics said it plans to submit a supplemental biologics license application to the FDA in the fourth quarter of 2026, with potential full approval anticipated in 2027.

According to the press release, Jonathan Barratt, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester, said the results show "TRUTAKNA achieved a physiologic rate of eGFR loss compared to the pathologic rate observed with placebo and significantly reduced the risk of composite kidney disease progression events."