Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 174

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 174
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 measured by UPCR as the primary endpoint, with secondary endpoints including the difference in kidney function between treated and placebo participants as measured by eGFR and reduction in Gd-IgA1. We completed enrollment of the Phase 2b ORIGIN trial in mid-2022, enrolling a total of 116 participants at multiple global sites. In January 2023, we announced that atacicept met the primary endpoint: the pooled 75 mg and 150 mg arms achieved a statistically significant reduction in proteinuria versus placebo at 24 weeks. In June 2023, we announced positive results at 36 weeks in a late-breaking presentation at the European Renal Association (ERA) Conference. In a prespecified per-protocol (PP) analysis in which a blinded third-party CRO identified and excluded participants with protocol deviations, atacicept 150 mg achieved a 43% mean reduction in proteinuria versus placebo, and a 35% mean reduction in proteinuria versus placebo in the intent-to-treat (ITT) population. Stable eGFR was observed for participants on atacicept 150 mg at 36 weeks, with an 11% mean eGFR change versus placebo, approximating to an absolute difference of 5.8 mL/min/1.73m2. Atacicept 150 mg reduced Gd-IgA1 64% from baseline and resolved hematuria in 80% of participants receiving atacicept 150 mg compared to 5% of those receiving placebo. Furthermore, Atacicept was well tolerated, and its safety profile in IgAN was comparable to placebo. The ORIGIN 2b trial remained blinded through 36 weeks, after which all participants were eligible to roll onto the open label portion of the trial and receive atacicept 150 mg once weekly through 96 weeks, allowing for the evaluation of long-term safety and durability of response of atacicept in IgAN. In October 2024, we simultaneously announced positive results through 96 weeks with a late breaking presentation at ASN Kidney Week and a publication in the Journal of the American Society of Nephrology (JASN). Through 96 weeks of treatment, atacicept demonstrated further reductions in Gd-IgA1, hematuria resolution, reductions in UPCR, and eGFR stabilization at a rate of decline similar to the general population without kidney disease. The open label extension adverse events profile was consistent with the randomized period