Vera Therapeutics, Inc. announced results from a prespecified per-protocol (PP) analysis of the Phase 2b ORIGIN clinical trial of atacicept in patients with IgA nephropathy (IgAN) following announcement of topline results on January 3, 2023. The prior topline results reflected the intent-to-treat (ITT) analysis of all randomized patients (n=116), which is a conservative assessment of efficacy. In the prespecified PP analysis, the population was defined as patients who had completed treatment according to protocol (n=102).

14 patients across treatment arms who had protocol violations were identified by a blinded third-party CRO and excluded, for prespecified reasons as outlined. Atacicept is the Company's potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite available ACE or ARB therapy.

In the topline results published on January 3, 2023, all treated patients (n=116) were included in the results as the intent-to-treat (ITT) population. In the prespecified PP analysis, the population was defined as patients who had completed treatment according to protocol (n=102), where 14 patients who had protocol violations identified by a blinded third-party CRO were excluded. These protocol violations are outlined above.

In the PP analysis, at Week 24, the atacicept 150 mg dose group achieved a 41% mean reduction in proteinuria versus baseline and a 34% delta versus placebo (p=0.025). With interim data at Week 36, the atacicept 150 mg dose group achieved a 47% mean reduction in proteinuria from baseline and a 48% delta versus placebo. Data for the atacicept 150 mg dose group versus placebo from both the PP and ITT analyses can be referenced.

Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, including a 1% discontinuation rate due to adverse events (AEs) and comparable rates of infection compared to placebo. Serious treatment-emergent AEs were observed in 2% of patients in all atacicept arms and in 9% of patients in the placebo arm. These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date – in which atacicept was well-tolerated.

Vera is continuing to rapidly advance atacicept into pivotal Phase 3 development, which is anticipated in the first half of 2023, subject to and following discussions with the FDA. The full data sets from the ORIGIN clinical trial will be presented at upcoming medical congresses. Vera plans to prioritize and focus current resources on the advancement of atacicept in IgAN into a pivotal Phase 3 trial, extending cash runway to the fourth quarter of 2024.

This updated cash runway guidance assumes a delay in enrollment in the pivotal Phase 3 trial for lupus nephritis, and a delay of commitment of resources to the MAU868 program until regulatory agreement is reached regarding the pivotal Phase 3 program for the treatment of BK viremia in kidney transplant recipients.