Vera Therapeutics reports ‘positive’ data from ORIGIN Phase 3 trial of atacicept

Vera Therapeutics (VERA) announced data from the ORIGIN Phase 3 trial of atacicept in IgA nephropathy were presented as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology Kidney Week 2025 and simultaneously published in The New England Journal of Medicine. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio, with a statistically significant and clinically meaningful 42% reduction in UPCR compared to 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% and hematuria was resolved in 81% of participants with baseline hematuria. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. In the ORIGIN 3 full analysis set, the incidence of adverse events was generally balanced between the atacicept and placebo groups, with fewer serious adverse events reported with atacicept than placebo, and no safety signals indicating immunosuppression. There were no deaths in either treatment group.