TRUTAKNA Meets Efficacy Endpoints in IgA Nephropathy Final Analysis

Vera Therapeutics has announced that its drug TRUTAKNA (atacicept-vymj) has met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial for adults with primary IgA nephropathy (IgAN) at risk for disease progression. The analysis, which included 428 patients, showed that TRUTAKNA stabilized estimated glomerular filtration rate (eGFR) and prevented kidney disease progression through two years of treatment.

The results are significant because they align with the Kidney Disease: Improving Global Outcomes (KDIGO) treatment goal of reducing the rate of kidney function decline to the physiologic rate (<1 mL/min/1.73m2/year). TRUTAKNA also achieved statistically significant reductions in proteinuria, galactose-deficient IgA1 (Gd-IgA1), and hematuria. These findings underscore the drug's potential to comprehensively modify the disease.

The favorable safety profile of TRUTAKNA is consistent with previous results from the ORIGIN program. Rates of overall adverse events and infections or infestations were similar between the TRUTAKNA and placebo groups, and there were no opportunistic infections or clinically relevant hypogammaglobulinemia.

Vera Therapeutics plans to submit a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for full approval in the fourth quarter of 2026.

Since receiving accelerated approval, Vera Therapeutics has seen significant interest from the IgAN community. In the first ten weeks, the company generated over 350 patient start forms.

IgA nephropathy is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide. Approximately 2.5 adults per 100,000 are diagnosed with IgAN each year, most often between 30 and 40 years of age. Over time, IgAN can lead to irreversible kidney damage and may ultimately require dialysis or kidney transplantation. At least 50% of patients may progress to kidney failure or death within 10 to 20 years of diagnosis.

TRUTAKNA, a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor, is a soluble recombinant fusion protein containing the human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines BAFF and APRIL. BAFF and APRIL are key cytokines that activate B cells and drive IgAN pathophysiology. In IgAN, activated B cells produce both the antigen and associated antibodies that result in the production of damaging IgA immune complexes. The overlapping roles of BAFF and APRIL in activating B cells support the potential for TRUTAKNA as a disease-modifying therapy.

TRUTAKNA is self-administered as an at-home, small-volume (1 ml), 150 mg once-weekly autoinjector. The drug is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

The company's TRUTAKNA TRU SUPPORT™ Patient Support Program is dedicated to ensuring that eligible IgAN patients can access the first approved therapy that targets both BAFF and APRIL. TRUTAKNA TRU SUPPORT offers insurance coverage assistance, financial assistance options for eligible patients, and educational resources designed to support patient access and care. Eligible commercially insured patients may pay as little as $0 out of pocket through the copay assistance program.

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company's flagship commercial product is TRUTAKNA, a BAFF and APRIL inhibitor indicated to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful.