Vera Therapeutics reported that Trutakna stabilized kidney function and reduced disease progression during the final two-year analysis of its Phase 3 ORIGIN 3 trial.
The study evaluated Trutakna in adults with immunoglobulin A nephropathy, commonly known as IgAN, who were at risk of progressive kidney damage.
Patients receiving Trutakna experienced a 76% reduction in the risk of composite kidney-disease progression compared with placebo through 104 weeks.
Eleven progression events occurred in the Trutakna group, compared with 38 among patients receiving placebo. No Trutakna-treated patients required prolonged dialysis, kidney transplantation or died during the analysis period, compared with eight such events in the placebo group.
The drug also demonstrated a significant effect on estimated glomerular filtration rate, or eGFR, an important measure of kidney function.
At 52 weeks, the average eGFR change was negative 0.1 milliliters per minute per 1.73 square meters for Trutakna patients, compared with a decline of 5.7 for the placebo group.
Through 104 weeks, the annualized eGFR decline was 0.6 for Trutakna versus 5.6 for placebo. Vera said the result indicates that kidney-function loss among treated patients approached the rate expected from normal aging.
Trutakna met all prespecified efficacy endpoints, including measures involving protein in the urine, galactose-deficient IgA1 and blood in the urine.
The company also said the treatment’s safety profile remained generally comparable with placebo. Rates of overall adverse events and infections were similar, with no opportunistic infections or clinically significant reductions in antibody levels reported.
Trutakna received accelerated FDA approval in July 2026 based primarily on its ability to reduce proteinuria. Accelerated approval allows treatments for serious conditions to reach patients based on an intermediate measure that is considered reasonably likely to predict clinical benefit.
The new two-year data provide evidence involving kidney function and disease progression, which are more direct measures of long-term patient outcomes.
Vera plans to submit a supplemental biologics license application during the fourth quarter of 2026 seeking full FDA approval. The company believes a decision could arrive in 2027.
Commercial adoption has begun following the accelerated approval. Vera generated more than 350 patient-start forms during the first 10 weeks of the launch.
IgAN is an immune-mediated disease in which harmful deposits build up in the kidneys. Over time, the condition can lead to irreversible damage, dialysis or transplantation.
The final ORIGIN 3 results could strengthen Trutakna’s position within an increasingly competitive IgAN treatment market. For Vera, converting the drug’s accelerated authorization into full approval would remove an important regulatory condition and provide stronger evidence supporting long-term use.
