Vera Therapeutics' Atacicept Receives FDA Breakthrough Therapy Designation for IgAN
Vera Therapeutics, a biotechnology company specializing in treatments for serious immunological conditions, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for atacicept in the treatment of IgA nephropathy (IgAN).
This designation reflects atacicept’s potential to significantly enhance treatment outcomes compared to existing therapies, based on promising data from the Phase 2b ORIGIN clinical trial.
The Breakthrough Therapy Designation aims to accelerate the development and review of drugs for serious conditions that show preliminary evidence of substantial benefits over current treatments.
In the Phase 2b ORIGIN trial, atacicept stabilized estimated glomerular filtration rate (eGFR) over 72 weeks, suggesting it may be a significant improvement over current treatments. The trial had a 36-week double-blind phase followed by 36 weeks of open-label treatment.
The upcoming Phase 3 ORIGIN 3 trial (NCT04716231) will evaluate atacicept 150 mg in IgAN patients with persistent proteinuria despite RAASi therapy. This global study will feature a 4-week screening phase, a 104-week double-blind treatment period, a 52-week open-label extension, and 26 weeks of follow-up, focusing on changes in proteinuria and eGFR.
The primary objective is to assess changes in proteinuria from baseline to week 36, with secondary objectives including annualized changes in eGFR.
IgA nephropathy (IgAN), or Berger’s disease, is a severe autoimmune kidney disorder caused by the accumulation of Gd-IgA1, leading to immune complex formation, kidney inflammation, and damage. Up to 50% of patients may progress to end-stage kidney disease (ESKD), affecting their quality of life.
Atacicept, an investigational fusion protein, targets the cytokines BAFF and APRIL, which are involved in B-cell survival and autoantibody production. By binding these cytokines, Atacicept aims to reduce autoantibodies associated with autoimmune diseases like IgAN and lupus nephritis. Administered to over 1,500 patients in clinical studies, it shows promise as a leading treatment by targeting B cells and plasma cells.
