Vera Therapeutics Releases Interim Analysis Of Rare Kidney Disease Drug, Deprioritizes Certain Phase 3 Programs

Vera Therapeutics Inc VERA has announced results from a prespecified per-protocol (PP) analysis of the Phase 2b ORIGIN trial of atacicept in IgA nephropathy (IgAN) patients.
The company says the prior topline results, announced in early January, 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 the protocol (n=102).
Fourteen patients across treatment arms with protocol violations were identified by a blinded third-party CRO and excluded.
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.
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.
Safety results indicated that atacicept was generally well-tolerated and was consistent with the previously observed safety profile of atacicept.
Vera is continuing to rapidly advance atacicept into pivotal Phase 3 development, anticipated in the first half of 2023.
Vera plans to prioritize and focus current resources on advancing atacicept in IgAN into a pivotal Phase 3 trial, extending the 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 in the commitment of resources to the MAU868 program until a regulatory agreement is reached regarding the pivotal Phase 3 program for BK viremia in kidney transplant recipients.
Price Action: VERA shares are up 3.55% at $9.05 during the premarket session on the last check Monday.