Vera Therapeutics, Inc. (Nasdaq: VERA) has announced the completion of enrollment for the primary endpoint in its pivotal Phase 3 ORIGIN 3 trial of atacicept in patients with Immunoglobulin A Nephropathy (IgAN). The trial, designed to evaluate the safety and efficacy of atacicept, reached its target of 200 participants ahead of schedule. Topline data from the ORIGIN 3 trial is anticipated in Q2 2025.
The ORIGIN 3 trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. It aims to assess the impact of atacicept on proteinuria and the preservation of renal function in IgAN patients who exhibit persistent proteinuria and remain at high risk of disease progression. Patients self-administer atacicept via subcutaneous injection once weekly.
Positive Phase 2b Data and Breakthrough Therapy Designation
According to Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics, atacicept continues to generate broad interest following positive data from the ORIGIN Phase 2b trial. Results from the Phase 2b trial indicated stabilized kidney function through 72 weeks and rapid reductions in hematuria in patients receiving atacicept. These results led to the FDA granting atacicept Breakthrough Therapy Designation earlier this year.
"We believe atacicept is well positioned to be one of the first B cell modulators to be approved for IgAN and provide a new foundation for treating this organ-threatening disease," said Dr. Fordyce.
Vera Therapeutics also expects to present 96-week data from its ORIGIN Phase 2b trial in Q4 2024.
About Atacicept
Atacicept is an investigational recombinant fusion protein containing the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor. It binds to B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), cytokines that promote B-cell survival and autoantibody production associated with autoimmune diseases like IgAN and lupus nephritis.
The Phase 2b ORIGIN trial demonstrated statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile was comparable between atacicept and placebo during the randomized period. Through 72 weeks, atacicept showed further reductions in Gd-IgA1, hematuria, and proteinuria, along with stabilization of eGFR, aligning with the profile of the general population without IgAN.
IgAN and Unmet Needs
IgAN, also known as Berger's disease, is a leading cause of kidney failure. It is characterized by the buildup of immunoglobulin A (IgA) in the kidneys, leading to inflammation and damage. Current treatments often fail to prevent disease progression, highlighting the need for new therapeutic options.
