Trutakna (atacicept-vymj) / EMD Serono, Vera Therap - LARVOL DELTA

Atacicept: First Approval. (PubMed, Drugs) - "In patients with IgAN, atacicept produced sustained reductions in proteinuria across the ORIGIN clinical development program and stabilized estimated glomerular filtration rates through 96 weeks. This article summarizes the milestones in the development of atacicept leading to this first approval for IgAN."

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

Atacicept-vymj. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

Atacicept in IgA nephropathy. (PubMed, Expert Rev Clin Immunol) - "This is a very promising finding, and long-term results with atacicept, and a similarly promising BAFF and APRIL inhibitors, telitacicept and povetacicept in nephropathy are eagerly awaited. Of particular interest is whether long-term suppression of immunoglobulins with these inhibitors has adverse effects. Further trials will be needed to determine the respective roles of these inhibitors with angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) and/or sodium-glucose cotransporter 2 (SGLT 2) inhibitors in IgA nephropathy."

Journal • Review • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Efficacy and safety of BAFF/APRIL-pathway inhibitors versus placebo in adults with IgA nephropathy: a systematic review with pairwise and network meta-analysis. (PubMed, BMC Nephrol) - "In adults with IgAN, BAFF/APRIL-pathway inhibitors consistently and substantially reduced proteinuria versus placebo, with a small short-term eGFR difference and no evident short-term safety signal, although longer follow-up is required to define uncommon, infectious, and immunological risks. Whether this antiproteinuric effect, seen over approximately 6 to 12 months, translates into durable preservation of kidney function remains uncertain. The between-agent and biomarker estimates are exploratory, and longer trials reporting kidney-failure endpoints are needed to confirm a disease-modifying effect."

Clinical • Journal • Retrospective data • Review • Glomerulonephritis • IgA Nephropathy • Renal Disease

Sibeprenlimab (Voyxact) for primary immunoglobulin A nephropathy. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P2b | N=116 | Active, not recruiting | Sponsor: Vera Therapeutics, Inc. | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P3 | N=376 | Recruiting | Sponsor: Vera Therapeutics, Inc. | Phase classification: P2b ➔ P3

Phase classification • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P2b | N=492 | Recruiting | Sponsor: Vera Therapeutics, Inc. | Active, not recruiting ➔ Recruiting | N=116 ➔ 492 | Trial completion date: Jul 2024 ➔ Jul 2028 | Trial primary completion date: Mar 2023 ➔ Jun 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P2b | N=116 | Active, not recruiting | Sponsor: Vera Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P3 | N=376 | Active, not recruiting | Sponsor: Vera Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P2b; N=105; Recruiting; Sponsor: Vera Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

ORIGIN: Atacicept in Subjects With IgA Nephropathy (clinicaltrials.gov) - P2b; N=105; Not yet recruiting; Sponsor: Vera Therapeutics, Inc.

Clinical • New P2b trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA for Adult Patients with Primary IgA Nephropathy (GlobeNewswire) - "In a prespecified interim analysis of the ongoing ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks....Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing ORIGIN 3 trial, which continues in a placebo-controlled, blinded manner to evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR), with results anticipated in Q3 2026."

Accelerated approval • FDA approval • P3 data • IgA Nephropathy

ORIGIN EXTEND: A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept (clinicaltrials.gov) - P2 | N=750 | Enrolling by invitation | Sponsor: Vera Therapeutics, Inc. | N=476 ➔ 750 | Trial completion date: May 2028 ➔ May 2031 | Trial primary completion date: May 2028 ➔ May 2031

Enrollment change • Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease • CST3

Efficacy and safety of B-cell directed therapies in IgA nephropathy: A collaborative meta-analysis (ERA 2026) - "Results Results We identified 8 eligible trials evaluating B-cell directed therapies (sibeprenlimab, atacicept, povitacicept, telitacicept, felzartamab) in 1408 participants with IgAN. Conclusion Conclusion In patients with IgA nephropathy at risk of disease progression, B-cell directed therapies reduce proteinuria and stabilise kidney function, without increasing the risk of serious adverse events or infection. These findings support the role of B-cell directed therapies as a foundational disease‑modifying treatment strategy in patients with IgAN at risk of kidney function loss."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

Comparative Effectiveness and Preliminary Network Pharmacology of Telitacicept, Leflunomide and Mycophenolate Mofetil for IgA Nephropathy (ERA 2026) - "In the 12th month, the eGFR increase in the TACI-Ig group was the largest compared to baseline and the result was statistically significant, suggesting that TACI-Ig can maintain stable eGFR in IgAN patients and has a more positive long-term prognosis. 3 . This study utilizes network pharmacology analysis combined with molecular docking methods to speculate that targets such as ESR1, PPARG, and CASP3 play a significant role in the mechanism of action of LEF and MMF in the treatment of IgAN, providing more treatment options for those who cannot access medications."

HEOR • IO biomarker • Atherosclerosis • Glomerulonephritis • IgA Nephropathy • Immunology • Primary Immunodeficiency • Renal Disease • CASP3 • ER • PD-L1 • PPARG

Studying Post-Transplant IgA Nephropathy in PIONEER, a Basket Trial of Atacicept in Autoimmune Glomerular Disease (ATC 2026) - "PIONEER will provide the first evaluation of atacicept in post-transplant IgAN recurrence."

Pan tumor • Post-transplantation • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease • Transplantation

Targeting BAFF and APRIL with Atacicept: Clinical Evidence and Future Directions (ERA 2026) - "Supported by Vera Therapeutics."

Clinical • IgA Nephropathy • Renal Disease

ISS2.9: Emerging Therapeutic Approaches in IgA Nephropathy: Innovations in B-Cell Modulation and Dual BAFF/APRIL Inhibition (ERA 2026) - "Distinguished international experts will examine the roles of BAFF and APRIL within B-cell biology and IgAN, evaluate clinical trial outcomes for novel interventions—including dual BAFF/APRIL inhibition via atacicept—and discuss implications for patient management...Attendees will gain valuable insights into the pathophysiology of IgAN, the scientific rationale for modulating B-cell pathways, and the clinical evidence underpinning emerging treatment paradigms. The session will conclude with a panel discussion designed to provide practical perspectives on incorporating these innovations into clinical practice and to consider future directions for research."

Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Renal Disease

PIONEER: A Basket Trial of Atacicept in Autoimmune Glomerular Diseases (ERA 2026) - No abstract available

Pan tumor • Immunology • Renal Disease

ORIGIN EXTEND: Assessment of IgAN Disease Markers During Atacicept Off‑Treatment Period (ERA 2026) - No abstract available

Glomerulonephritis • IgA Nephropathy

ORIGIN 3: Subgroup Analysis of a Phase 3 Trial of Atacicept in IgA Nephropathy (ERA 2026) - No abstract available

P3 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Vera Therapeutics, Inc…announced it has aligned with the U.S. Food and Drug Administration (FDA) on a revised, earlier ORIGIN 3 eGFR analysis plan to support full approval for atacicept in adults with IgAN. (Vera Therap Press Release) - "The eGFR results are now expected in the third quarter of 2026. Pending these results, Vera Therapeutics plans to submit an sBLA for full approval in the fourth quarter of 2026."

FDA filing • P3 data • IgA Nephropathy

Natural History Model of Lifetime Burden of Immunoglobulin A Nephropathy (IgAN) in the United States (NKF-SCM 2026) - "CONCLUSION Using supportive therapy alone results in progressive decline of kidney function and high incremental costs. B-cell modulators such as atacicept may improve quality of life and reduce long-term burden associated with IgAN by preserving kidney function."

Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease

Comparative Network Meta-Analysis (NMA) of Sibeprenlimab Efficacy in the Treatment of Immunoglobulin A Nephropathy (IgAN) (NKF-SCM 2026) - "Treatments analyzed were: sibeprenlimab, atacicept, atrasentan, sparsentan, cemdisiran, TRF-budesonide, ravulizumab, and iptacopan. CONCLUSION Sibeprenlimab demonstrates clinically significant reductions in uPCR compared with other treatments, suggesting potential in IgAN. Updated NMA will be conducted when full Phase 3 results for sibeprenlimab are available."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Renal Disease