Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 188

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 188
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 autoimmune diseases, and we intend to explore additional immunologic diseases where BAFF and APRIL are abnormally elevated, or where autoantibodies play an important role.

UPCR is an accepted surrogate primary endpoint for clinical trials in IgAN, which potentially allows for a faster path to commercialization than rate of change/slope in eGFR, which is determined with two years of data. The recommendation for usage of 

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this surrogate endpoint was put forward by the ASN, partnering with the FDA under the auspices of the Kidney Health Initiative, and the European Medicines Agency (EMA), and has now been implemented in five Phase 3 clinical trials in IgAN and in the three FDA approvals granted. Accelerated and/or conditional approval may be granted on the UPCR endpoint, with full approval to be granted upon longer-term data demonstrating stabilization of eGFR with treatment.

Ongoing Phase 3 ORIGIN clinical trial

We advanced atacicept 150 mg into a pivotal Phase 3 trial in IgAN in the second quarter of 2023, using the same formulation from the Phase 2b trial and learnings from the Phase 2b subgroup analyses to reduce risk in the design of a Phase 3 trial that aims to accurately assess treatment efficacy while minimizing potential confounders for proteinuria measure. 

Figure 10: Phase 3 ORIGIN 3 trial design

ORIGIN 3 is a Phase 3 global, multicenter, randomized, placebo-controlled, double-blind trial (Figure 10) in participants with IgAN who have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of renin-angiotensin system inhibitors (ACE inhibitors or ARBs) for at least 12 weeks that is the maximum labeled or tolerated dose. The clinical trial consists of a 104-week double-blind treatment period which is currently ongoing, followed by a 52-week open-label extension and a 26-week safety follow-up period. The trial will assess at-home self-administered once weekly 1-mL subcutaneous injections of atacicept 150 mg versus placebo on impact of kidney function as measured by proteinuria and eGFR. The primary endpoint is change from baseline in UPCR at 36 weeks based on 24-hour urine collection and the key secondary endpoint is eGFR up to 104 weeks. Additional secondary endpoints are change in Gd-IgA1, hematuria resolution, change in eGFR up to 52