Vera Therapeutics, Inc. (NASDAQ:VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, today announced completion of patient enrollment in the Phase 2b ORIGIN clinical trial of atacicept, the Company’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 dose-ranging study evaluating the efficacy and safety of atacicept in patients with IgA nephropathy (IgAN) who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of renin-angiotensin-aldosterone system inhibition (RAASi) with an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB).
“We have been seeking a disease modifying therapy for IgAN to potentially slow or reverse disease progression,” said Richard Lafayette, M.D., FACP, Professor of Medicine, Director, Stanford Glomerular Disease Center, Stanford University School of Medicine, and a clinical investigator in the trial. “Recently, new data analysis from the Phase 2a JANUS clinical trial in patients with IgAN, showed atacicept is the first known investigational therapeutic to reduce IgG autoantibodies as well as its autoantigen, Gd-IgA1 – the source of immune complexes that cause disease. This builds on the already compelling disease-modifying dose-dependent activity and well-tolerated safety profile for atacicept. We look forward to the results of the ORIGIN trial which will be a first for the field.”
“We are excited to complete enrollment in the Phase 2b ORIGIN trial and reach this significant milestone for atacicept as we work diligently amidst a global pandemic and geopolitical crises to provide a much-needed treatment option for patients with IgAN,” said Celia Lin, M.D., Chief Medical Officer at Vera Therapeutics. “IgAN represents a high unmet medical need in the world, with an estimated 400,000 patients in the U.S., the European Union, and Japan – up to half of whom will develop end-stage renal disease within 20 years from initial diagnosis, requiring dialysis or kidney transplant. We believe atacicept could have a profound benefit for patients with IgAN and look forward to topline results of this study expected to be announced later this year.”
The ORIGIN clinical trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled Phase 2b trial evaluating the safety and efficacy of atacicept in 115 patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regiment of RAASi for at least 12 weeks that is the maximum labeled or tolerated dose. The objectives of the study are to determine the effect of atacicept on proteinuria and preservation of renal function compared to placebo to determine the appropriate dose(s) for further clinical development.
The ORIGIN trial is designed to evaluate three dose strengths of atacicept versus placebo, administered weekly by prefilled syringe, and their impact on the reduction of proteinuria as evaluated by urine protein to creatinine ratio (UPCR). Subjects were randomized 2:2:1:2 to atacicept 150 mg, atacicept 75 mg, atacicept 25 mg, or matching placebo. Upon completion of the 36-week blinded treatment period, all subjects will be offered open-label atacicept 150 mg for an additional 60 weeks.
The primary endpoint is the change in proteinuria as evaluated by UPCR at week 24 and the key secondary endpoint is the change in proteinuria as evaluated by UPCR at week 36. Additional secondary and exploratory endpoints include change in proteinuria as evaluated by UPCR at weeks 12, 48, and 96; rate of change in estimated glomerular filtration rate (eGFR); change in serum immunoglobulin levels, and serum Gd-IgA1 levels; safety and tolerability; and serum pharmacokinetics (PK). For more information about the ORIGIN clinical trial, please visit www.clinicaltrials.gov.
