Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 175

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 175
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. In aggregate, we believe these data provide evidence that atacicept offers a potential safe, long-term, disease-modifying treatment for patients with IgAN. 

We completed full enrollment for the primary endpoint of ORIGIN 3 in the second half of 2024. With Phase 3 topline results expected in the second quarter of 2025, if positive, we expect to submit a biologics license application (BLA) for atacicept in IgAN to the FDA in the second half of 2025. 

Pipeline

Beyond our lead indication in IgA nephropathy, we have several late-stage opportunities for potential patient benefit – consisting of both indication expansion opportunities for atacicept, and the development of VT-109 in B cell mediated diseases and MAU868 for BK viremia among kidney transplant recipients. We are currently evaluating these opportunities for future development. 

For atacicept, we plan to evaluate the possibility of extended dosing intervals as part of our life cycle management strategy. There are also multiple indications in which blocking BAFF and APRIL may offer therapeutic benefit and offer an attractive commercial opportunity. 

In January 2025, we announced a license agreement with Stanford University to acquire global rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL that is in preclinical development with wide therapeutic potential across the spectrum of B cell mediated diseases. These rights are for all therapeutic, prophylactic, diagnostic, and treatment uses in humans outside of cancer immunotherapy.

2

Regarding MAU868 for BK viremia among kidney transplant recipients, at ASN Kidney Week 2022, final results from the Phase 2 clinical trial of MAU868 versus placebo showed that MAU868 was well tolerated and demonstrated clinically meaningful reductions in BK antiviral activity through 36 weeks in kidney transplant patients with BK viremia. Following feedback from the FDA on the Phase 2 clinical trial, we are evaluating strategies for continued development, including a potential next clinical trial. 

MAU868 in BK viremia among kidney transplant recipients

We have exclusive worldwide rights, pursuant to the Novartis license, to MAU868, which is a potential treatment for reactivated BK infection in kidney transplant recipients. While up to 90% of healthy adults have been infected with BKV at some point in their lives, it remains latent except in severely immunocompromised populations such as kidney transplant recipients. BKV is a polyoma virus that can cause