Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 173

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 173
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, hematuria, and proteinuria – and stabilization of eGFR. 

We have worldwide, exclusive rights to atacicept from Ares, an affiliate of Merck KGaA, Darmstadt, Germany, pursuant to the Ares Agreement, which advanced atacicept in randomized, double-blind, placebo-controlled clinical trials for several autoimmune diseases in over 1,500 patients, in which it was well tolerated. In IgAN, Merck KGaA, Darmstadt, Germany, conducted a randomized, double-blind, placebo-controlled Phase 2a trial known as JANUS. Results from the JANUS trial showed a dose-dependent effect of atacicept 25 mg and 75 mg weekly on serum Gd-IgA1, proteinuria, and key biomarkers, including serum Ig levels. As reported at the American Society of Nephrology (ASN) Kidney Week conference in 2022, atacicept is also the first therapeutic candidate in IgAN to show reduction in all first three hits of disease pathogenesis—serum Gd-IgA1, anti-Gd-IgA1 autoantibody, and immune complex levels.

We are conducting a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical trial in IgAN, which we refer to as ORIGIN 3, and have completed the open label extension of our Phase 2b clinical trial in IgAN, which we refer to as ORIGIN 2b. The ORIGIN 3 trial is evaluating atacicept 150 mg by weekly subcutaneous injection at home versus placebo through 104 weeks. The primary endpoint is reduction in UPCR in a 24-hour urine collection versus placebo at 36 weeks to support potential accelerated approval. A significant reduction in proteinuria, as measured by UPCR in a 24-hour urine collection, is associated with improved renal outcomes in patients with IgAN. UPCR is a surrogate endpoint accepted by the FDA for primary glomerular diseases associated with significant proteinuria, including IgAN. Given the FDA’s recent approvals of TARPEYO and FILSPARI, we believe the use of proteinuria as a surrogate endpoint for accelerated approval has been validated. The key secondary endpoint is eGFR change up to week 104. 

The ORIGIN 2b trial evaluated three subcutaneous weekly doses of atacicept (25 mg, 75 mg and 150 mg) and their impact on the reduction of proteinuria as