The company revealed that the phase 2b ORIGIN clinical trial of atacicept met its primary and key secondary endpoints, with ‘statistically significant and clinically meaningful’ reductions in proteinuria and stabilization of eGFR through week 36.
The results were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress.
Atacicept
Atacicept is Vera’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 of the clinical trial, data 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.
In addition, atacicept was generally well-tolerated with a safety profile similar to placebo.
These positive results support atacicept 150 mg as a potential disease-modifying treatment for patients with IgA nephropathy, with Vera conducting a phase 3 (ORIGIN 3) clinical trial in June 2023.
Marshall Fordyce, CEO of Vera Therapeutics, said: “With these results from the phase 2b ORIGIN clinical trial at week 36, we believe the clinical results we have generated support atacicept as a potentially disease-modifying therapy for patients with IgAN.”
“With our confirmatory Phase 3 ORIGIN 3 clinical trial already recruiting, we are working to bring this potentially transformative therapy to patients with IgAN as quickly as possible with guidance from regulators and look forward to sharing future updates on our progress.”
Richard Lafayette, director of the Stanford Glomerular Disease Center, added: “The week 36 results of the Phase 2b ORIGIN clinical trial build on a growing body of data that demonstrates atacicept's potential to modify and delay disease progression in IgAN."
“We believe this is best characterized by the early signs of eGFR stabilization and a significant 43% reduction in proteinuria for the atacicept 150 mg group compared to placebo. These data also demonstrate the therapeutic potential of the BLyS and APRIL dual inhibitor approach to treating the root cause of IgAN.”