Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 178

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 178
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ologic diseases where BAFF and APRIL are abnormally elevated, or where autoantibodies play an important role. 

•Advance the development of VT-109 and explore its potential in multiple B-cell mediated diseases. We acquired rights to this novel, next-generation dual BAFF/APRIL inhibitor in January 2025 and plan to leverage our research, translational medicine, clinical development and commercial expertise in developing this program.

•Identify next clinical trial for MAU868 in BK viremia in kidney transplant recipients and align with regulatory authorities. We reported positive final results from our Phase 2 clinical trial in kidney transplant recipients in 2022 and are working to design our next clinical trial for MAU868. 

•Expand our pipeline by acquiring or in-licensing product candidates for immunologic diseases with unmet needs. We believe our expertise and track record will enable us to identify and acquire or in-license additional product candidates that represent opportunities to expand the potential value of our pipeline. We will leverage our lean clinical development operation to bring to market additional product candidates to address kidney and immunologic diseases.

Atacicept in IgAN 

We are developing atacicept as a potential treatment for patients with IgAN, a serious and progressive autoimmune disease of the kidney with a high unmet medical need and limited treatment options available. Up to 50% of confirmed IgAN patients progress to ESRD, requiring dialysis or kidney transplant. ESRD causes significant morbidity and impact on patients’ lives and represents a significant health economic burden estimated to be over $70 billion annually in the United States. Despite this high level of morbidity, the current standard of care consists of non-IgAN specific CKD therapies, including off-label use of RAAS inhibitors (ACE inhibitors and ARBs), increasing use of SGLT2 inhibitors, and potentially steroids. IgAN is driven by the production of pathogenic Gd-IgA1, and patients with elevated Gd-IgA1 are at increased risk of kidney-related morbidity and mortality. We reported positive topline 24-week results in January 2023, 36-week results in June 2023, and 96-week results in October 2024 from the Phase 2b ORIGIN trial. We initiated a pivotal Phase 3 clinical trial in the second quarter of 2023, which we refer to as ORIGIN 3, that is currently ongoing. We believe that atacicept has the potential to be the best-in-class,