Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 186

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 186
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 5.7 mL/min/1.73m2. Endpoint Gd-IgA1 levels significantly decreased from baseline by 60% versus placebo. The safety profile of atacicept was similar to placebo.

Vera reported positive results from the randomized phase of the Phase 2b ORIGIN clinical trial, which showed the following at 36 weeks:

•Gd-IgA1 reduction of 64% from baseline with atacicept 150 mg.

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•Hematuria resolution in 80% of participants on atacicept 150 mg versus 5% on placebo.

•In a Per Protocol (PP) analysis, a blinded third-party CRO identified participants with protocol deviations that potentially confounded proteinuria measure. In the PP population that excludes these participants, atacicept 150 mg achieved a 43% mean reduction in proteinuria versus placebo (p<0.05); in the ITT population, atacicept 150 mg achieved a 35% further decrease from placebo.

•Stable eGFR observed for participants on atacicept, with clinically meaningful and statistically significant difference versus placebo.

• Clinical safety profile similar between atacicept and placebo.

In October 2024, long-term results from the ORIGIN Phase 2b trial were simultaneously presented in a late breaking oral presentation at ASN Kidney Week 2024 and published in a manuscript in the Journal of the American Society of Nephrology (JASN). Over 96 weeks, participants treated with atacicept demonstrated a 66% reduction in Gd-IgA1, resolution of hematuria in 75% of participants, a 52% reduction in proteinuria, and a mean annualized eGFR slope of -0.6 mL/min/1.73m2/year. This eGFR slope profile is consistent with the aging-related decline observed in the general population without biopsy-proven kidney disease. The cumulative generally favorable safety profile of atacicept remained consistent with that observed during the randomized period, with a 90% completion rate of atacicept treatment in the open-label extension period. We believe these data support the potential for atacicept to offer long-term, comprehensive IgAN disease modification and provide further confidence in the ongoing pivotal Phase 3 ORIGIN trial of atacicept in IgAN.

Figure 7: ORIGIN Phase 2b long-term 96-week results with atacicept was consistent