ORIGIN EXTEND: A LONG-TERM EXTENSION STUDY OF ATACICEPT IN IgA NEPHROPATHY

 

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ORIGIN EXTEND: A LONG-TERM EXTENSION STUDY OF ATACICEPT IN IgA NEPHROPATHY

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Richard
Lafayette
Richard Lafayette czar@stanford.edu Stanford University Division of Nephrology, Department of Medicine Stanford United States *
Robert Brenner robert.brenner@veratx.com Vera Therapeutics, Inc. Medical Brisbane United States -
Laura Jiang laura.jiang@veratx.com Vera Therapeutics, Inc. Biostatistics Brisbane United States -
Jonathan Barratt jb81@leicester.ac.uk University of Leicester College of Medicine Biological Sciences and Psychology Leicester United Kingdom -
 
 
 
 
 
 
 
 
 
 
 

IgA nephropathy is a B-cell mediated disease associated with progressive, irreversible loss of kidney function and a high lifetime risk of kidney failure. Atacicept is a native human TACI-Fc fusion protein that binds B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), the key cytokines that drive B-cell activation central to the pathophysiology of IgA nephropathy. Atacicept is currently in late-stage clinical development for IgAN treatment. The ORIGIN Phase 2b study met the primary endpoint demonstrating a statistically significant and clinically meaningful UPCR reduction with atacicept compared to placebo at 24 weeks, with a further reduction and eGFR stabilization through 36 weeks. At 96 weeks, the open-label extension (OLE) period demonstrated sustained improvements in key markers that characterize disease modification, including reductions in Gd-IgA1, resolution of hematuria, reductions in UPCR, and stabilization of eGFR at a slope similar to that observed in the general population without kidney disease. The ORIGIN 3 study is an ongoing global, randomized, double-blind, Phase 3 study of atacicept 150 mg or placebo for 104 weeks followed by a 52 week OLE. Atacicept met the primary endpoint with a statistically significant UPCR reduction at 36 weeks and achieved secondary endpoints of Gd-IgA1 reduction and hematuria resolution. The ORIGIN 3 study design, participant population, and atacicept dose and subcutaneous (SC) formulation are consistent with ORIGIN 2b study.  Here we describe the ORIGIN Extend study which aims to capture longer-term safety and treatment outcomes while providing eligible patients with continued access to atacicept. 

ORIGIN Extend is a global, multicenter, open-label Phase 2 study to assess long-term safety, and efficacy of atacicept 150 mg for treatment of IgAN. Eligible participants will have completed the protocol-defined treatment period in the ORIGIN 2b or ORIGIN 3 clinical trials. Participants will receive atacicept 150 mg SC weekly injections, self-administered at home for up to 3 years.

Endpoints include long-term safety and tolerability for atacicept and its effect on changes in Gd-IgA1, hematuria, proteinuria and eGFR. This trial is ongoing.

The ORIGIN Extend study will capture longer-term data on the disease-modifying potential of atacicept in IgAN while providing eligible patients with continued access to atacicept.

1. Barratt J. JASN 2024.

This abstract was also presented at the ASN Kidney Week 2025 and ERA 2025 congresses.

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