Vera Therapeutics has announced positive 72-week data from the open label extension (OLE) period of its Phase IIb ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN).
In aggregate, the 72-week data with atacicept are consistent with a profile of true disease modification in IgAN.
“The demonstration of stable eGFR well beyond a year in participants receiving atacicept represents an important potential advancement for IgAN patients and has potential implications for the future treatment paradigm in this disease. It is also exciting that the data from the OLE show that switching to atacicept halted the eGFR decline seen in participants initially treated with placebo,” stated Richard Lafayette, Professor of Medicine, Nephrology and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center.
Participants treated with atacicept for 72 weeks demonstrated a 62% reduction in Gd-IgA1, a reduction in the percentage of participants with haematuria to 19%, and a 48% reduction in UPCR in the per-protocol (PP) analysis.
Importantly, participants had consistent and stable eGFR with 0mL/min/1.73m2 change from baseline at 72 weeks. Of note, it has been shown that eGFR declines by approximately 1mL/min/1.73m2 per year in the general population (Baba M, et al. PLOS ONE 2015).
“We believe these data further support our belief that atacicept has the disruptive potential to stand out as a disease-modifying treatment for patients with IgAN,” said Marshall Fordyce, Chief Executive Officer of Vera Therapeutics.
Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). These cytokines are members of the tumour necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis.