Core Insights - Vera Therapeutics announced that the ORIGIN Phase 3 trial of atacicept for immunoglobulin A nephropathy (IgAN) met its primary endpoint, demonstrating significant efficacy in reducing proteinuria [1][7]. Efficacy Results - Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio (UPCR), and a 42% reduction compared to placebo at week 36 (p<0.0001) [2][7]. - Other prespecified endpoints showed results consistent with or better than those observed in the ORIGIN Phase 2b trial [2][7]. Safety Profile - The safety profile of atacicept was favorable and comparable to that of the placebo [2][7]. Regulatory Plans - Vera plans to share these results with the FDA and intends to submit a Biologics License Application (BLA) for atacicept in IgAN in the fourth quarter of 2025, potentially allowing for US approval and commercial launch in 2026 [4][7]. Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN, with participants receiving either atacicept 150 mg or placebo [5][7]. - The trial continues to evaluate changes in kidney function over two years, with completion expected in 2027 [5][7]. Company Vision - Vera Therapeutics aims to advance the standard of care in IgAN and other autoimmune kidney diseases, aspiring to evolve kidney medicine practices [4][12].

Core Insights - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [3] - The company will participate in the TD Cowen 45th Annual Health Care Conference from March 3 – 5, 2025, including a fireside chat and one-on-one investor meetings [1][2] Company Overview - Vera's mission is to advance treatments targeting the source of immunological diseases to change the standard of care for patients [3] - The lead product candidate, atacicept, is a fusion protein administered subcutaneously once weekly, designed to block B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases like IgAN and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody aimed at neutralizing BK virus infections, particularly in kidney transplant settings [3] - The company retains all global developmental and commercial rights to both atacicept and MAU868, and has an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, targeting BAFF and APRIL [3]