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Vera Therapeutics Announces Positive Week 36 Efficacy and Safety Results of Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN in Late-Breaking Presentation at 60th European Renal Association (ERA) Congress
New data at week 36 shows atacicept 150 mg resulted in a delta of 43% versus placebo in mean proteinuria reduction in per-protocol analysis and demonstrated
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"New data at week 36 shows atacicept 150 mg resulted in a delta of 43% versus placebo in mean proteinuria reduction in per-protocol analysis and demonstrated statistically significant stabilization of eGFR versus placebo in this high-risk population Atacicept was well tolerated with safety profile similar to placebo Positive results support atacicept 150 mg as a potential disease-modifying treatment for patients with IgA nephropathy; Phase 3 (ORIGIN 3) clinical trial initiated in June 2023 Conference call and webcast to take place on June 20th, 2023, at 8:00 a.m. ET to further discuss results BRISBANE, Calif., June 17, 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 the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. The week 36 results of ORIGIN were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023, in Milan, Italy and virtually. Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite available ACEi or ARB therapy. At week 36 in the prespecified per-protocol (PP) analysis, the atacicept 150 mg dose group showed a 43% placebo-adjusted reduction from baseline in proteinuria (p=0.003), compared to 35% in the intent-to-treat (ITT) analysis (p=0.012), as shown in Figure 1 below. In the ITT analysis of all randomized patients, patients receiving placebo had an expected decline in kidney function as measured by eGFR, while patients receiving atacicept 150 mg had stable eGFR through week 36, as shown in Figure 2. This difference in eGFR was statistically significant (delta 11%, p=0.038) and clinicall...