Company: VERA
Filing Date: 2025-12-10
Form Type: 424B5
Source: 0001193125-25-314244
Chunk: 3

Company: Vera Therapeutics, Inc.
Filing Date: 2025-12-10
Form: 424B5
Chunk 3
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 of 200 participants that will provide data for the 36-week urine protein creatinine ratio, or UPCR, primary efficacy endpoint. We
announced primary endpoint results in the second quarter of 2025 and submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration through the Accelerated Approval Program on November 7, 2025. The Phase 2b
ORIGIN clinical trial evaluated the safety and efficacy of atacicept in 116 participants with IgAN and reported positive results at 24 weeks in January 2023, 36 weeks in June 2023, and 96 weeks in October 2024. The trial remained blinded through 36
weeks, after which all participants were eligible for the open-label extension portion of the study and received atacicept 150 mg through 96 weeks. At 24 and 36 weeks, atacicept met its primary and key secondary endpoints, respectively, with
statistically significant reductions in UPCR, and stable estimated glomerular filtration rate, or eGFR, was observed with clinically meaningful and statistically significant difference for participants on atacicept versus placebo. Participants
treated with atacicept demonstrated reductions in galactose-deficient IgA1, or Gd-IgA1, the autoantigen produced by B cells in patients with IgAN, and a reduction in hematuria. The improvements in Gd-IgA1, hematuria, UPCR and eGFR represent the quartet of findings consistent with IgAN disease modification. The 96-week open-label extension results showed consistent and
sustained reductions in Gd-IgA1, hematuria, and UPCR, with continued eGFR stabilization at a rate similar to the general population without kidney disease. Additionally, atacicept’s safety profile was
comparable to placebo. We have also committed to providing long-term access to atacicept for all ORIGIN participants through ORIGIN EXTEND, a long-term Phase 2 extension study that offers open-label atacicept to participants who completed ORIGIN
Phase 2b or 3 until commercial availability in their country or region. We believe that atacicept has pipeline in a molecule potential, with potential application in multiple diseases. Based on data from the Phase 2b ORIGIN trial, the U.S. FDA
granted Breakthrough Therapy Designation to atacicept for the treatment of