Vera Therapeutics Expands Atacicept Program for Autoimmune Kidney Diseases

Vera Therapeutics, Inc., a biotechnology firm in the late clinical stages, has announced the expansion of its development pipeline for atacicept, its leading asset. The company aims to extend its treatment capabilities, building on the positive results from the ongoing ORIGIN Phase 2b and 3 clinical programs for treating IgA nephropathy (IgAN). This expansion will include a broader population of IgAN patients and other autoimmune kidney conditions.

Dr. Marshall Fordyce, Founder and CEO of Vera Therapeutics, emphasized the promising clinical data revealed over the past year. He noted that the company's understanding of atacicept's disease-modifying mechanism has grown, suggesting its potential as a best-in-class treatment for IgAN patients. Vera Therapeutics aims to ensure long-term access to atacicept for all ORIGIN participants, while the new PIONEER study will significantly expand this opportunity to more IgAN patients.

Fordyce also highlighted the potential of B cell modulation through BAFF/APRIL dual inhibition to revolutionize the treatment of other autoimmune diseases. This includes primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease. The company is set on completing the pivotal clinical program for atacicept in IgAN and looks forward to achieving several significant milestones across its pipeline.

The ORIGIN Extend study is scheduled to begin in Q4 2024, offering ORIGIN participants continued access to atacicept before its commercial availability in their regions and allowing for the collection of long-term data. The PIONEER study, set to start in 2025, will assess the efficacy and safety of atacicept in various expanded IgAN populations. These include adults with low kidney function, varying levels of proteinuria, those experiencing IgAN recurrence post-kidney transplant, and adolescents at high risk of progression. Additionally, the study will cover autoimmune glomerular diseases characterized by antibodies to glomerular antigens, such as primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease.

The new indications present a significant opportunity for atacicept, with the combined peak prevalence of IgAN and autoimmune-driven diseases like PMN, FSGS, and MCD in the U.S. estimated at around 230,000 cases. Vera Therapeutics believes that atacicept also holds potential for treating additional rheumatologic and hematologic conditions.

The announcement was made during Vera’s R&D Day in New York, featuring academic leaders Jonathan Barratt, Richard Lafayette, and Brad Rovin. The event anticipated the upcoming 96-week data from the Phase 2b ORIGIN study of atacicept in IgAN, which will be presented as a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024.

Vera Therapeutics is dedicated to developing transformative treatments for serious immunological diseases. The company's mission is to advance therapies that target the root causes of these diseases, aiming to set new standards of care for patients. Atacicept, their leading product candidate, is a fusion protein administered as a subcutaneous injection once a week. It blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies linked to autoimmune diseases like IgAN and lupus nephritis. Vera is also exploring the potential of atacicept in other diseases where reducing autoantibodies might be beneficial.

Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infections, which can have severe consequences, particularly in kidney transplant settings. The company retains all global developmental and commercial rights to atacicept and MAU868.