Vera Therapeutics Announces Phase 3 ORIGIN 3 Results for TRUTAKNA (Atacicept-vymj): Sustained Kidney Function and 76% Risk Reduction in IgA Nephropathy

Vera Therapeutics has released the final efficacy data from its pivotal Phase 3 ORIGIN 3 clinical study evaluating TRUTAKNA™ (atacicept-vymj) in 428 adult patients diagnosed with primary IgA nephropathy (IgAN) who were at significant risk of disease progression. The trial demonstrated durable preservation of renal function and a substantial decline in disease progression events over a two-year evaluation window.

Key Clinical Efficacy Outcomes

eGFR Stabilization at Week 52: Patients in the TRUTAKNA cohort showed a mean change in estimated glomerular filtration rate (eGFR) of -0.1 mL/min/1.73 m², compared with a decline of -5.7 mL/min/1.73 m² in the placebo arm, establishing a statistically robust placebo-adjusted benefit of 5.6 mL/min/1.73 m².
Two-Year Annualized eGFR Slope: Over 104 weeks, the annualized rate of eGFR decline was preserved at -0.6 mL/min/1.73 m² per year for TRUTAKNA versus -5.6 mL/min/1.73 m² per year for placebo.
Reduction in Progression Risk: TRUTAKNA achieved a 76% relative risk reduction in the composite kidney disease progression endpoint (hazard ratio of 0.24). Only 11 patients on TRUTAKNA met the composite event criteria compared to 38 patients in the control group.
Severe Renal Endpoints: Zero patients treated with TRUTAKNA experienced dialysis (lasting ≥30 days), kidney transplantation, or death through 104 weeks, compared to 8 events in the placebo group.
Biomarker Reductions: Statistically significant improvements were confirmed across secondary endpoints, including sustained reductions in proteinuria, hematuria, and pathogenic galactose-deficient IgA1 (Gd-IgA1) levels.

Safety Profile and Tolerability

Comparable Adverse Events: Overall adverse events and infection rates were balanced between the active treatment and placebo arms.
Targeted B-Cell Safety: No cases of opportunistic infections or clinically meaningful hypogammaglobulinemia were reported throughout the 104-week evaluation.

Mechanism, Regulatory Roadmap, and Outlook

Dual Cytokine Inhibition: TRUTAKNA is a recombinant fusion protein that functions as a dual inhibitor of BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand), neutralizing key drivers of autoantibody production in IgAN.
Dosing Regimen: Delivered via a 150 mg subcutaneous injection administered once weekly.
Regulatory Path: Granted accelerated approval by the U.S. FDA in July 2026, Vera Therapeutics intends to submit a supplemental Biologics License Application (sBLA) in Q4 2026 to transition TRUTAKNA from accelerated to traditional approval, with a regulatory decision projected for 2027.