Vera Therapeutics to expand development pipeline for atacicept

Vera Therapeutics announced expansion of its development pipeline for its lead asset, atacicept. This program is expected to build on the positive data reported to date from the ongoing ORIGIN Phase 2b and 3 clinical program developing atacicept to treat patients with IgAN, by extending into a broader population of IgAN and other autoimmune kidney indications. “Based on the positive clinical data announced over the past year, we have a greater understanding of atacicept’s disease-modifying mechanism of action and potential to be a best-in-class treatment option for patients with IgAN. We’re committed to providing long-term access to atacicept for all ORIGIN participants, and the PIONEER study will expand that opportunity to a significantly greater number of patients with IgAN,” said Marshall Fordyce,, Founder and CEO of Vera Therapeutics. The company plans to initiate a study in Q4 2024 that will provide ORIGIN participants with extended access to atacicept prior to commercial availability in their region, as well as an opportunity to capture longer-term data. PIONEER Study – In 2025, the company plans to initiate a study evaluating the efficacy and safety of atacicept in: expanded IgAN populations – The first set of cohorts will include adults with low kidney function, low or high proteinuria, or IgAN recurrence after kidney transplant; adolescents at high risk of progression; as well as adolescents and adults with IgA vasculitis nephritis. The PIONEER study will expand to additional autoimmune glomerular diseases characterized by the presence of antibodies to glomerular antigens, including primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease. These new indications represent a significant potential opportunity for atacicept, with the combined peak prevalence of IgAN and autoimmune-driven PMN, FSGS, and MCD in the US estimated at ~230,000. The company believes atacicept may have therapeutic potential in additional rheumatologic and hematologic indications.