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Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN
On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025)U.S. FDA BLA submission for accelerated approval planned for 2H 2025
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025)U.S. FDA BLA submission for accelerated approval planned for 2H 2025 BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today 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 U.S. 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, hematuria 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 ...