Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 189

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 189
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 weeks, and time from randomization to first occurrence of composite kidney failure endpoint event.

We completed enrollment for the Phase 3 primary endpoint cohort in September 2024 and anticipate full enrollment of the study in the second quarter of 2025. The Phase 3 primary endpoint results are expected in the first half of 2025, and, if supportive, we expect to submit a BLA to the FDA for accelerated approval of atacicept in IgAN in the second half of 2025.

ORIGIN EXTEND Phase 2 clinical trial

We initiated the ORIGIN EXTEND trial, a Phase 2 extension study in participants who complete ORIGIN Phase 2b or Phase 3. The objectives of the trial are to 1) provide patients with extended access to atacicept prior to commercial availability in their country or region; 2) capture longer-term data for research purposes; and 3) generate data from reinitiation of atacicept treatment following an off-treatment period. We anticipate clinical results from the trial in 2025 and 2026.

Initiation of PIONEER Phase 2 Study to assess Atacicept in pMN, FSGS, and MCD

Due to the positive results of the ORIGIN Phase 2b clinical trial, and following discussions with the FDA, we plan to initiate a new Phase 2 clinical trial for atacicept to treat patients with nephrotic syndrome who have biomarkers that may predict a positive response to B cell modulation. The PIONEER study will initiate in 2025 and will study atacicept in additional autoimmune glomerular diseases characterized by the presence of antibodies to glomerular antigens, including within primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). We anticipate clinical results from the trial in 2025 and 2026.

Atacicept in primary membranous nephropathy (pMN)

pMN Pathophysiology and Disease Overview

pMN is an autoimmune disease characterized by glomerular membrane thickening and long-term proteinuria. pMN patients are initially treated with ACEi / ARBs, and upon progression typically are treated with either immunosuppressive or CD20 therapies. Despite proper management, patients still progress to ESRD, highlighting the need for a more effective standard of care.

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pMN Market Opportunity, Current Standard of Care, and