Vera Therapeutics(VERA) Newsfilter·2025-04-03 12:00Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [9] - Atacicept is a recombinant fusion protein that targets B-cell activating factors, aiming to reduce autoantibody production associated with autoimmune diseases like IgAN and lupus nephritis [5][9] - The company is also developing MAU868, a monoclonal antibody for BK virus infections, and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [9] Clinical Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, while the key secondary endpoint assesses kidney function via estimated glomerular filtration rate (eGFR) through 104 weeks [3] - The ORIGIN Phase 2b trial previously demonstrated significant reductions in proteinuria and stabilization of kidney function, reinforcing the potential of atacicept as a best-in-class therapy for IgAN [6]