Abstract: SA-OR079
Interim Results from the Adult IgAN and Primary Membranous Nephropathy (pMN) Cohorts in the Atacicept PIONEER Trial
Session Information
- Late-Breaking Research Orals: Pediatrics, Genetics, and Glomerular Diseases
October 24, 2026 | Location: Four Seasons Ballroom 2, Convention Center
Abstract Time: 05:42 PM - 05:54 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Lafayette, Richard A., Stanford University, Stanford, California, United States
- Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom
- Mix, Chris, Vera Therapeutics Inc, Brisbane, California, United States
- Rizk, Dana V., University of Alabama at Birmingham Health System, Birmingham, Alabama, United States
- Rovin, Brad, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- Winterberg, Pamela D., Vera Therapeutics Inc, Brisbane, California, United States
- Sheng, Tao, Vera Therapeutics Inc, Brisbane, California, United States
- Tumlin, James A., Emory University School of Medicine, Atlanta, Georgia, United States
- Chertow, Glenn M., Stanford University School of Medicine, Stanford, California, United States
- Wanner, Christoph, Julius-Maximilians-Universitat Wurzburg, Würzburg, BY, Germany
Background
Several glomerular diseases result from B-cell-driven production of antibodies that mediate kidney injury. Atacicept is a native human TACI-Fc fusion protein that inhibits BAFF and APRIL, key cytokines that drive B-cell activity. In ORIGIN 2b/3, atacicept reduced proteinuria and improved IgAN disease markers. PIONEER is a global, open-label, Phase 2 trial evaluating atacicept in multiple antibody-mediated glomerular diseases, including presentations of IgAN excluded from ORIGIN 2b/3 and anti-PLA2R-positive pMN.
Methods
Adults receive atacicept 150 mg SC weekly for 52 weeks. IgAN cohorts include reduced eGFR (<30 mL/min/1.73 m2), moderate proteinuria (UPCR 0.5–1.0 g/g), high proteinuria (≥5 g/g), IgA vasculitis with nephritis (IgAVN), and post-transplant recurrence. Objectives include safety/tolerability and change from baseline (BL) in proteinuria and disease-specific antibodies (Gd-IgA1, anti-PLA2R).
Results
94 adults with IgAN, including 14 with IgAVN and 6 with post-transplant recurrence are included in this Aug 2026 analysis. Mean change from BL in 24h-UPCR was –34% (SE 3.2) at Week 12 and –41% (SE 7.7) at Week 24 with similar reductions seen across adult IgAN cohorts. The analysis also includes 10 adults with pMN. Mean change from BL in anti-PLA2R antibody level at Week 4 was –63% (SE 6.0), with 1 of 7 achieving anti-PLA2R <14 RU/mL. Change from BL 24h-UPCR at Week 12 was -32% (SE 6.9), with 3 of 3 achieving resolution of BL nephrotic-range proteinuria. No new safety signals or clinically significant hypogammaglobulinemia have been observed. Updated analyses will be presented.
Conclusion
Atacicept treatment in adults with IgAN and low eGFR or low proteinuria at BL resulted in similar reductions in 24h-UPCR as reported in ORIGIN 2b/3. In adults with pMN, atacicept treatment resulted in rapid reduction in anti-PLA2R antibody levels, detectable at Week 4, the earliest reported response to a B-cell modulatory therapy in pMN, and similar in magnitude as B-cell depleting therapies at this time point. These findings support the broader therapeutic potential of atacicept across these antibody-mediated glomerular diseases.
Funding
- Commercial Support – Vera Therapeutics