Vera Therapeutics announces efficacy, safety results Phase 2b ORIGIN trial

Vera Therapeutics announced the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. Atacicept is the company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator and a proliferation-inducing ligand. 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 analysis, the atacicept 150 mg dose group showed a 43% placebo-adjusted reduction from baseline in proteinuria, compared to 35% in the intent-to-treat analysis, 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 and clinically significant. In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1. Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, with no increased rate of infections compared to placebo, a low rate of serious adverse events overall, and no drug discontinuations or interruptions due to hypogammaglobulinemia. Serious treatment-emergent adverse events were observed in 3% of patients receiving atacicept 150 mg and in 9% of placebo patients. These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date across different indications – in which atacicept was well-tolerated.