Vera Therapeutics reports Phase 2 results of atacicept in IgA nephropathy

Vera Therapeutics 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. ORIGIN is a 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. "This new analysis of proteinuria reduction in the ORIGIN Phase 2b clinical trial shows atacicept’s ability to substantially reduce proteinuria, independent of changes in background regimens in the context of a multinational, randomized, placebo-controlled trial," said Jonathan Barratt, Professor of Renal Medicine, University of Leicester, U.K. CEO Marshall Fordyce said, "…Our team is well positioned to begin the pivotal trial in the first half of the year, subject to and following discussions with the FDA. With current timelines, we expect to announce Week 36 topline data from the Phase 3 clinical trial in the first half of 2025. Pending the data from the Phase 3 clinical trial, we expect to submit a BLA for atacicept to the FDA in the second half of 2025." 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 placebo2. 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. 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 4Q24.