Kidney Week

Abstract: INFO10-FR

ORIGIN Extend: A Rollover Extension Study to Continue to Evaluate the Long-Term Safety and Efficacy of Atacicept

Session Information

• Informational Posters - 2
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• No subcategory defined

Authors

• Lafayette, Richard A., Stanford University School of Medicine, Stanford, California, United States

Richard A. Lafayette, MD

• Cooper, Kerry, Vera Therapeutics, Inc., Brisbane, California, United States

Kerry Cooper, MD

• Wei, Xuelian, Vera Therapeutics, Inc., Brisbane, California, United States

Xuelian Wei

• Barratt, Jonathan, University of Leicester, Leicester, United Kingdom

Jonathan Barratt, MBChB, PhD

Group or Team Name

• ORIGIN Study Team.

Description

Background
IgA nephropathy (IgAN) is a B-cell mediated kidney disease that often leads to end stage kidney disease.^1,2 B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) bind to the TACI receptor on B cells and play a crucial role in their maturation, differentiation, and effector function. Dysregulated B cells produce galactose-deficient IgA1 (Gd-IgA1), which is recognized as an autoantigen by anti-Gd-IgA1 autoantibodies, forming immune complexes that are central to IgAN pathogenesis. Atacicept, a fully humanized TACI-Fc fusion protein that binds BAFF and APRIL to modulate the activity of dysregulated B cells, has been shown to reduce circulating Gd-IgA1, anti-Gd-IgA1, and immune complexes, and is a potential disease-modifying approach to treating IgAN.
The safety and efficacy of atacicept has been evaluated in the Phase 2b ORIGIN trial, which demonstrated eGFR stabilization and reductions in Gd-IgA1, hematuria, and proteinuria through 72 weeks, with comparable safety to placebo.³ Atacicept has received FDA Breakthrough Therapy Designation based on data from this trial. The ongoing ORIGIN 3 trial is a global, randomized, double-blind, placebo-controlled Phase 3 trial of atacicept 150 mg or placebo for 104 weeks followed by a 52 week open-label extension.
Study Design
ORIGIN Extend is a global multicenter Phase 2 trial to evaluate long-term safety, tolerability, and efficacy of atacicept 150 mg for treatment of IgAN. Eligible participants must have completed the protocol-defined treatment period in a Vera-sponsored clinical trial (ie, parent study). Participants will receive atacicept 150 mg self-administered at home via subcutaneous weekly injection for up to 3 years or until atacicept is commercially available in their region. The ORIGIN Extend study will enable continued access for participants of a parent study and provide extended long-term data for atacicept in IgAN.
¹Kwon CS. J Health Econ Outcomes Res 2021
²Pitcher D. Clin J Am Soc Nephrol 2023
³Lafayette R. Nephrol Dial Transplant 2024;abstr 812

Funding

• Vera Therapeutics, Inc.