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 clinically significant (5.8 mL/min/1.73 m2). In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1 (p<0.0001).
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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 clinically significant (5.8 mL/min/1.73 m2). In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1 (p<0.0001).