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Vera Therapeutics Initiates Pivotal Phase 3 (ORIGIN 3) Clinical Trial of Atacicept for the Treatment of IgA Nephropathy (IgAN)
Pivotal Phase 3 Trial for Atacicept in IgA Nephropathy Initiated Today Late-breaking results of ORIGIN Phase 2b trial supporting further evaluation of
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"Pivotal Phase 3 Trial for Atacicept in IgA Nephropathy Initiated Today Late-breaking results of ORIGIN Phase 2b trial supporting further evaluation of atacicept 150 mg as a potential disease-modifying treatment for IgAN will be presented at 60th European Renal Association (ERA) Congress BRISBANE, Calif., June 07, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced initiation of the pivotal Phase 3 clinical trial (ORIGIN 3) of atacicept for the treatment of IgA nephropathy (IgAN). ORIGIN 3 is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept 150 mg in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite optimized angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) therapy. Atacicept is a potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). The ORIGIN 3 trial was initiated based on the results of the Phase 2b trial, which will be presented in a late-breaking session at the 60th European Renal Association (ERA) Congress in June 2023. “Building upon positive data from our Phase 2b trial that show atacicept’s best-in-class potential, initiation of the pivotal ORIGIN 3 trial is a crucial milestone in the advancement of its clinical development,” said Marshall Fordyce, M.D., Chief Executive Officer of Vera Therapeutics. “Our Phase 2 results have shown that atacicept targets the source of IgA nephropathy and improves kidney function as measured by statistically and clinically significant reductions in proteinuria. As we enroll this pivotal Phase 3 trial, we plan to share longer term Phase 2 results later in 2023 and 2024.” About the Phase 3 clinical trial (ORIGIN 3)The ORIGIN 3 clinical trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of atacicept 150 mg in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribe...