Vera Reports Positive Two-Year IgAN Data; Plans to Seek Full Approval for Trutakna

Rare Daily Staff

Vera Therapeutics said its drug Trutakna slowed the loss of kidney function and reduced the risk of serious kidney-disease progression over two years in adults with IgA nephropathy, a rare immune-driven kidney disease that can eventually lead to dialysis or transplantation.

The results come from the final analysis of the Phase 3 ORIGIN 3 trial, which enrolled 428 adults with primary IgA nephropathy, or IgAN, who were considered at risk of disease progression. The company said it plans to submit the data to the U.S. Food and Drug Administration in the fourth quarter of 2026 to seek full approval for the medicine.

IgAN is a chronic autoimmune kidney disease in which abnormal forms of the antibody immunoglobulin A, or IgA, form immune complexes that can lodge in the kidneys. The deposits can trigger inflammation and progressive damage. For patients, worsening disease can lead to increasing protein in the urine, blood in the urine, high blood pressure, fatigue and swelling—and, eventually, kidney failure. Some people ultimately require dialysis or a kidney transplant.

Trutakna is designed to block two immune-system signaling proteins, BAFF and APRIL. These proteins help activate B cells, which may contribute to production of the abnormal immune molecules involved in IgAN. The medicine is administered as a once-weekly, self-injection using an autoinjector. According to Vera, it is the first FDA-approved treatment for IgAN to inhibit both BAFF and APRIL.

Trutakna received accelerated FDA approval to reduce proteinuria, or excess protein in the urine, in adults with primary IgAN who are at risk of disease progression. Proteinuria is an important marker of kidney damage. However, accelerated approval requires confirmatory evidence that a treatment provides clinical benefit, such as preserving kidney function or reducing progression to kidney failure.

In ORIGIN 3, Trutakna was compared with placebo. At 52 weeks, patients receiving Trutakna had essentially stable estimated glomerular filtration rate, or eGFR, a commonly used measure of how well the kidneys filter blood.

Patients who took Trutakna had essentially no change in kidney function on average during the study. Their eGFR—a standard measure of how well the kidneys filter blood—declined by just 0.1 points. By comparison, patients who received a placebo, or inactive treatment, had an average decline of 5.7 points. In other words, Trutakna was associated with kidney function that was about 5.6 eGFR points better than placebo over the study period.

Over two years, the Trutakna group’s kidney function declined at roughly one-tenth the rate seen in the placebo group. The company said that the slower decline was similar to the modest loss of kidney function that can occur with normal aging.

The trial examined a composite measure of kidney-disease progression. Eleven people in the Trutakna group experienced a progression event, compared with 38 people in the placebo group. Vera reported that this represented a 76 percent lower relative risk of progression for people treated with the drug.

The trial also assessed a composite measure of kidney-disease progression. Eleven people in the Trutakna group experienced a progression event, compared with 38 people in the placebo group. Vera reported that this translated to a 76 percent lower relative risk of progression among patients treated with the drug.

No patients receiving Trutakna required dialysis for at least 30 days, received a kidney transplant or died during the 104-week analysis period, compared with eight patients in the placebo group, according to the company.

“Prevention of kidney failure or kidney-related death is the ultimate goal,” said Richard Lafayette, a Stanford nephrologist and principal investigator in the trial. He said the two-year findings suggest that the treatment may help some patients avoid dialysis, transplantation or kidney-related death over the long term.

The company also said the treatment significantly reduced proteinuria, levels of an abnormal form of IgA associated with the disease, and blood in the urine. Detailed results have not yet been presented at a scientific meeting or published in a peer-reviewed journal.

Vera said Trutakna’s overall safety profile in the trial was generally comparable with placebo, with similar rates of overall adverse events and infections. The company reported no opportunistic infections and no clinically meaningful hypogammaglobulinemia, a condition marked by unusually low antibody levels.

Because the therapy suppresses parts of the immune system, however, infection remains an important consideration. In clinical studies cited in the prescribing information, infections were reported in 32 percent of people treated with Trutakna and 28 percent of those receiving placebo. The most common were upper respiratory tract infections. Injection-site reactions were also more common among people receiving the drug.