Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 187

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 187
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 with disease-modifying IgAN profile

Atacicept safety and tolerability profile

In the randomized phase of the ORIGIN Phase 2b clinical trial, the clinical safety profile was similar between atacicept and placebo – and in the 96-week results, the safety profile observed was consistent with that of the randomized phase (Figure 8 below).

Figure 8: Phase 2b ORIGIN clinical trial adverse events profile

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In an integrated safety analysis of clinical trials for multiple indications with over 1,500 participants, atacicept was well tolerated, as shown in Figure 9 below. Serious treatment-emergent adverse events (TEAEs) reported in the highest proportions were infections and infestations (placebo 3.9% versus atacicept 4.4%), musculoskeletal and connective tissue disorders (placebo 1.9% versus atacicept 1.3%), and nervous system disorders (placebo 2.1% versus atacicept 1.2%). The most frequently reported TEAE was pneumonia (placebo 1.2% versus atacicept 1.3%). We believe that this large and established data set is a competitive advantage for atacicept versus other approved and emerging therapies in development, many of which lack extensive safety data.

Figure 9: Integrated safety analysis: Summary of treatment-emergent adverse events > 5% in any arm, by dose

The safety profile of atacicept 25 mg, 75 mg and 150 mg has been characterized in healthy subjects and patients with RA, multiple sclerosis, optic neuritis, SLE, and B cell malignancies, and is considered acceptable in IgAN. Over 2,213 individuals have been enrolled in ongoing and completed interventional clinical trials with atacicept, of which over 1,635 individuals have received at least one dose of atacicept. As of February 19, 2025, 647 participants with SLE from five Phase 2/3 clinical trials have received at least one dose of atacicept, and 124 participants with IgAN from two Phase 2 clinical trials have received at least one dose of atacicept. An additional estimated 180 patients are being dosed with atacicept in the ongoing blinded ORIGIN Phase 3 study.

We believe the benefit-risk balance of atacicept to be favorable for further development in IgAN and certain additional