Vera Therapeutics, Inc., a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, announced that it has completed full enrollment in the pivotal ORIGIN phase 3 trial of atacicept in patients with IgA Nephropathy (IgAN).
“We are grateful for the IgAN community’s strong interest in the clinical development of atacicept that helped drive us towards completing full enrollment in the ORIGIN 3 trial with a total of 431 participants. Complete enrollment represents another key milestone on the path to potential approval of the first B cell modulator targeting both BAFF and APRIL for IgAN,” said Marshall Fordyce, M.D., founder and CEO of Vera Therapeutics. “We anticipate the 36-week primary efficacy endpoint data from the trial this quarter, which supports our planned Biologics License Application for an accelerated approval to the US FDA in the second half of 2025. ORIGIN 3 follows the positive long-term results from the ORIGIN phase 2b trial that demonstrated sustained and substantial reductions in Gd-IgA1, haematuria and proteinuria, and showed stabilized kidney function through 96 weeks, positioning atacicept as a potential best-in-class IgAN therapy. Pending the submission and thorough FDA review of the BLA, we would look forward to a potential PDUFA date and commercial launch in 2026.”
The ORIGIN 3 trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria and remain at high risk of disease progression. Participants are randomized 1:1 to at-home self-administered once-weekly subcutaneous injections of atacicept 150 mg or placebo for a 104-week double-blind period, followed by a 52-week open-label extension.
The primary efficacy endpoint is the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) through 36 weeks in an interim analysis of at least 200 participants. The key secondary efficacy endpoint is change in kidney function as measured by estimated glomerular filtration rate (eGFR) through 104 weeks in the full study population.
In addition, the company is currently conducting the ORIGIN Extend trial, which provides extended access to atacicept for participants from the ORIGIN phase 2b or phase 3 trials until commercial availability in their region, and captures longer-term safety and efficacy data.
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 tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis.
The phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN.
Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients.
