Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 172

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 172
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idity and impact on patients’ lives and represents a significant health economic burden, which was estimated to be $70.6 billion in the United States in 2022. Despite this high level of morbidity, only three treatments have been approved for this indication: TARPEYO (budesonide, developed by Calliditas Therapeutics AB), a reformulated steroid, FILSPARI (sparsentan, developed by Travere Therapeutics), a dual endothelin angiotensin receptor antagonist, and FABHALTA (iptacopan, developed by Novartis), a complement inhibitor. None of these agents have been shown to reduce the rate of eGFR decline to a level that minimized the lifetime risk of kidney failure, and thus are not disease-modifying treatments in IgAN. The current standard of care continues to consist of non-specific CKD therapies such as off-label use of renin-angiotensin-aldosterone system (RAAS) inhibitors, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), and, in some patients, sodium-glucose cotransporter-2 (SGLT2) inhibitors. We estimate the global market opportunity for novel, disease-modifying therapeutics in IgAN is approximately $6.0 billion to $10.0 billion annually, based on the disease prevalence and the segment of IgAN patients at high risk of progressing to ESRD.

Atacicept is a TACI-Fc fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases. We believe that atacicept’s mechanism has the potential to generate clinical success by measures designed to assess efficacy in IgAN and other immunologic diseases. BAFF inhibition has been clinically and commercially validated through the approval of Benlysta (belimumab) in both systemic lupus erythematosus (SLE) and lupus nephritis (LN). Preclinical and clinical evidence support that atacicept’s mechanism of 

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dual inhibition of BAFF and APRIL may provide improved clinical outcomes, measured by endpoints designed to assess efficacy, compared to inhibiting either signal alone. Atacicept has the potential to be the first disease-modifying therapy for IgAN due to its ability to precisely modulate B cell activity, with reductions in Gd-IgA1