Vera Therapeutics looks well placed for full approval of Trutakna (atacicept-vymj) in primary IgA nephropathy (IgAN) after successful confirmatory data.
In the Phase III ORIGIN 3 trial (NCT04716231), patients treated with Trutakna saw a 0.1mL/min/1.73m2 reduction in mean estimated glomerular filtration rate (eGFR) change from baseline at 52 weeks, compared with a 5.7mL/min/1.73m2 reduction in the placebo group.
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Looking longer term, the annualised eGFR slope through 104 weeks was just a 0.6 drop in the treatment arm compared with 5.6 in the placebo cohort.
Kidney disease progression was also reduced, with no patients requiring dialysis for more than 30 days or transplant in the treatment group, while eight patients in the placebo cohort required this. The composite kidney disease progression was also reduced, with 11 events in the treatment group and 38 in the placebo cohort.
The drug also achieved statistically significant reductions in the hierarchically tested endpoints of proteinuria, galactose-deficient IgA1 (Gd-IgA1), and haematuria.
In July 2026, the US Food and Drug Administration (FDA) granted Trutakna accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression.
This was based on interim analysis from ORIGIN 3, in which patients treated with the study drug achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo at 36 weeks.
This newest data supports full approval of the drug, said Dr Marshall Fordyce, founder and CEO of Vera Therapeutics.
“We believe that upstream inhibition of BAFF and APRIL with Trutakna achieves results that reflect the potential for comprehensive disease modification in IgAN. The final results support this alignment, and we plan to submit the supplemental BLA in the fourth quarter of this year. We look forward to the potential full approval of Trutakna in 2027,” Fordyce said.
In the 10 weeks since the drug gained accelerated approval, the company has received over 350 patient start forms, showing strong patient and physician interest in the therapy.
Trutakna is a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor. The drug contains the human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines BAFF and APRIL.
IgAN market growing
While this data is promising for Vera, it comes amid a growing market for IgAN. In August, Otsuka shared positive two-year data for Voyxact (sibeprenlimab-szsi), which was found to stabilise kidney function for more than two years in IgAN patients.
In the Phase III VISIONARY trial (NCT05248646), eGFR was stabilised with an annualised estimated eGFR slope of 0.3mL/min/1.73 m²/year with Voyxact compared to a 4.2mL/min/1.73 m²/year reduction with placebo, meeting the study’s key secondary endpoint.
In February 2026, Novartis presented the final data from its Phase III ALIGN trial of Vanrafia (atrasentan) in IgAN. The randomised, global, double-blind, placebo-controlled, multi-centre trial showed a 2.39ml / min / 1.73m² difference in eGFR change from baseline as compared to placebo at week 136, four weeks after ending treatment. At the time, the pharma company said it would seek full FDA approval.
In March 2026, Vertex announced it would be seeking approval of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, after the Phase III RAINER trial (NCT06564142) met its primary endpoint.
More established therapies include Calliditas Therapeutics’ Tarpeyo (budesonide), which gained accelerated approval from the FDA in 2021, and Travere Therapeutics’ Filspari (sparsentan), which gained accelerated approval in 2023. The two drugs then went on to win full approvals in December 2023 and September 2024, respectively.
