Vera Therapeutics Reports Positive Phase 3 Data in IgAN

Rare Daily Staff

Vera Therapeutics said its experimental therapy atacicept met the primary endpoint in a phase 3 study in people with IgA nephropathy, a rare kidney disease.

Vera reported the results in a late-breaking oral presentation during the opening plenary session of the American Society of Nephrology Kidney Week 2025 and simultaneously published them in The New England Journal of Medicine.

IgA nephropathy (IgAN), also known as Berger’s disease, is a serious and progressive autoimmune disease of the kidney for which there remains a high unmet medical need. IgAN is driven by the production of immunogenic Gd-IgA1, which triggers autoantibodies that lead to the formation of pathogenic immune complexes. These complexes become trapped in the kidney’s glomeruli, causing inflammation and progressive damage. In up to 50 percent of patients, IgAN can lead to end-stage renal disease (ESRD) or kidney failure, which has considerable morbidity and impact on patients’ lives.

Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor. It binds to the cytokines B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases.

Participants treated with atacicept achieved a 46 percent reduction from baseline in proteinuria, as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42 percent reduction in UPCR compared with placebo at week 36.

Proteinuria efficacy was consistent across prespecified subgroups of age, sex, race, region, baseline proteinuria, baseline eGFR, and baseline SGLT2i use. Atacicept treatment also led to improvements in secondary endpoints: Gd-IgA1 was reduced by 68 percent, and hematuria was resolved in 81 percent of participants with baseline hematuria.

Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable and comparable to placebo. There were no safety signals indicating immunosuppression and no deaths in either treatment group.

“These results support our planned BLA submission to the FDA for atacicept in IgAN, and we look forward to a potential approval and U.S. commercial launch in 2026. If approved, we believe atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor,” said Marshall Fordyce, founder and CEO of Vera Therapeutics. “Vera Therapeutics is laser-focused on delivering atacicept to IgAN patients and further investigating its potential to treat other autoimmune kidney diseases.”

Photo: Marshall Fordyce, founder and CEO of Vera Therapeutics