Vera Therapeutics' TRUTAKNA cuts IgAN progression risk 76% in Phase 3
Vera Therapeutics has reported final two-year efficacy data from its Phase 3 ORIGIN 3 trial of TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy (IgAN), showing the drug met every prespecified endpoint and cut the risk of composite kidney disease progression by 76% versus placebo.
The 428-patient readout, announced on 15 September 2026, showed that patients on TRUTAKNA experienced a mean eGFR change from baseline of just -0.1 mL/min/1.73m² at 52 weeks, compared with -5.7 mL/min/1.73m² in the placebo group, a treatment effect of 5.6 mL/min/1.73m² (p<0.0001). The annualised eGFR slope through 104 weeks was -0.6 mL/min/1.73m²/year for TRUTAKNA versus -5.6 for placebo, aligning with the KDIGO 2025 guideline target of keeping annual function decline below 1 mL/min/1.73m²/year. Eleven patients on TRUTAKNA experienced a composite kidney disease progression event compared with 38 on placebo (hazard ratio 0.24; 95% CI 0.12, 0.48). Notably, zero patients on TRUTAKNA required dialysis for 30 days or more, underwent transplant, or died from kidney-related causes during the trial, versus eight in the placebo group.
Richard Lafayette, professor of nephrology at Stanford University Medical Center and a principal investigator for ORIGIN 3, said the results offered "evidence suggesting that TRUTAKNA may help patients avoid dialysis, transplantation, or kidney-related death over the long term" - a statement that carries particular weight given that at least half of IgAN patients historically progress to kidney failure or death within 10 to 20 years of diagnosis.
TRUTAKNA's safety profile was described as generally comparable to placebo. Infection rates were 32% versus 28% in the placebo group; no opportunistic infections or clinically relevant hypogammaglobulinaemia were observed.
Regulatory path and commercial outlook
Vera plans to submit a supplemental biologics licence application to the FDA in Q4 2026, seeking conversion of TRUTAKNA's existing accelerated approval, granted on the basis of proteinuria reduction, to full approval. The company is targeting a full approval decision in 2027. ORIGIN 3 is notable for being the first reported Phase 3 IgAN trial to reach agreement with the FDA on an earlier final efficacy analysis timepoint, which allowed placebo patients to cross over to open-label treatment sooner.
On the commercial side, chief commercial officer Matt Skelton reported over 350 patient start forms in the first ten weeks since TRUTAKNA's launch, with paid claims already coming through and initial payer policies described as favourable.
Market context
The IgAN treatment landscape has expanded significantly in recent years following decades in which supportive care was effectively the only option. TRUTAKNA, a soluble fusion protein that inhibits both BAFF and APRIL cytokines upstream of the B-cell cascade, holds a distinct mechanistic position from the endothelin and angiotensin pathway agents and from the selective IgA-protease approach pursued by other developers. Sparsentan and budesonide-based formulations such as nefecon have received regulatory attention in IgAN, and a number of complement-pathway inhibitors are in late-stage development. The two-year eGFR stabilisation data from ORIGIN 3 will now set a comparative benchmark that rivals will need to address in their own confirmatory programmes. For Vera, full approval would remove the confirmatory-trial contingency that currently sits on the label and should broaden payer coverage in the United States and support ex-US regulatory filings.