Soure: Vera Therapeutics
On June 17, 2023, Vera Therapeutics, a biotechnology company focused on immunological diseases, announced positive results from the Phase IIb ORIGIN trial of atacicept as a treatment for IgA nephropathy (IgAN). The trial met its primary and key secondary endpoints, demonstrating significant reductions in proteinuria and stabilization of estimated glomerular filtration rate (eGFR) up to week 36. The findings were presented at the 60th European Renal Association Congress.
Atacicept is a dual inhibitor of the cytokines BLyS and APRIL, and ORIGIN assessed its efficacy and safety in patients with IgAN who had persistent proteinuria and were at high risk of disease progression despite current therapy. The analysis at week 36 showed a 43% reduction in proteinuria compared to placebo in the per-protocol analysis, and a 35% reduction in the intent-to-treat analysis. Patients in the placebo group experienced a decline in kidney function, while those receiving atacicept 150 mg maintained stable eGFR. The difference in eGFR was statistically and clinically significant. Additionally, the atacicept group achieved a significant reduction in Gd-IgA1 levels.
Safety results showed that atacicept was generally well-tolerated, with no increased rate of infections compared to placebo. Serious adverse events were minimal, and there were no discontinuations or interruptions due to hypogammaglobulinemia. These findings build upon prior clinical trials of atacicept, supporting its favorable safety profile.
In conclusion, the Phase IIb ORIGIN trial demonstrated the efficacy of atacicept in reducing proteinuria and stabilizing kidney function in patients with IgA nephropathy. These results highlight the potential of atacicept as a transformative treatment for this serious immunological disease.
