Core Insights - Vera Therapeutics announced positive data from the ORIGIN Phase 3 trial of atacicept for IgA nephropathy, presented at ASN Kidney Week 2025 and published in NEJM [1][2] Efficacy Results - Participants treated with atacicept showed a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo at week 36, with statistical significance (p<0.0001) [2][7] - Secondary endpoints also improved, with Gd-IgA1 reduced by 68% and hematuria resolved in 81% of participants with baseline hematuria [2] Safety Profile - The safety profile of atacicept was favorable and comparable to placebo, with fewer serious adverse events reported (1 event in atacicept group vs. 11 in placebo group) [3][11] - No deaths occurred in either treatment group, indicating a strong safety record [3] Clinical Significance - ORIGIN 3 is the first Phase 3 trial of a B-cell modulator in IgAN to demonstrate clinical improvements in key disease markers [4] - The consistent benefits across various subgroups suggest that atacicept may modify the disease course by targeting underlying pathophysiology [4] Regulatory and Commercial Plans - Vera Therapeutics plans to submit a Biologics License Application (BLA) to the FDA for atacicept in IgAN, with potential approval and commercial launch expected in 2026 [5][7] - The ORIGIN 3 trial continues to evaluate long-term kidney function changes over two years, with results expected in 2027 [6][7] Company Overview - Vera Therapeutics is focused on developing treatments for serious immunological diseases, with atacicept as its lead product candidate targeting B-cell activity to reduce autoantibodies [14] - The company is also exploring atacicept's potential in other autoimmune kidney diseases and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [14]