Vera Therapeutics Presents 72-week eGFR Stabilization and Rapid Hematuria Improvement in Phase 2b ORIGIN Study of Atacicept in IgAN at the 61st European Renal Association Congress

Core Insights - Vera Therapeutics announced positive results from its Phase 2b ORIGIN trial of atacicept for immunoglobulin A nephropathy (IgAN), demonstrating stabilized kidney function and rapid improvements in hematuria over 72 weeks [1][2][4] 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 [19] Clinical Trial Results - The Phase 2b ORIGIN trial showed that participants receiving atacicept for 72 weeks had stable estimated glomerular filtration rate (eGFR) and significant reductions in Gd-IgA1, hematuria, and urine protein to creatinine ratio (UPCR) [2][12] - Atacicept treatment resulted in hematuria resolution in 80% of participants compared to 5% in the placebo group, with significant improvements observed as early as 4 weeks after treatment initiation [4][12] - The trial met its primary and key secondary endpoints, indicating statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR compared to placebo [12] Upcoming Milestones - The company plans to present full 96-week data from the Phase 2b ORIGIN trial in the fourth quarter of 2024 and expects to complete enrollment for the pivotal Phase 3 ORIGIN 3 trial by the third quarter of 2024 [14][20] Safety Profile - The cumulative safety profile of atacicept was comparable to the randomized period, with a retention rate of 91% through 72 weeks, supporting its potential for long-term disease modification in IgAN [2][12] Disease Background - IgAN, also known as Berger's disease, is a serious autoimmune disease of the kidney that can lead to end-stage kidney disease in up to 50% of patients, highlighting the high unmet medical need for effective treatments [17]