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Vera Therapeutics Releases 36 Week Interim Analysis of Phase 2b Clinical Trial of Atacicept for the Treatment of IgA Nephropathy; Patients in the 150 mg Dose Group Achieved a Delta of 48% Versus Placebo in Mean Reduction in Proteinuria
Vera continuing plans to rapidly advance atacicept into a pivotal Phase 3 trial in 1H 2023; full data to be presented at upcoming medical congresses Company
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"Vera continuing plans to rapidly advance atacicept into a pivotal Phase 3 trial in 1H 2023; full data to be presented at upcoming medical congresses Company plans to prioritize and focus current resources on the advancement of atacicept in IgA Nephropathy into a pivotal Phase 3 trial, extending cash runway to Q4 2024 Conference call and webcast to take place on January 30th at 8:00am ET BRISBANE, Calif., Jan. 30, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, today 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 in Figure 1. Figure 1. Patients Identified by Blinded Third-Party CRO and Excluded from Prespecified PP Analysis 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. “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, Ph.D., FRCP, The Mayer Professor of Renal Medicine, University of Leicester, U.K. “We believe the PP analysis represents a more accurate assessment of treatment efficacy when compared to the ITT analysis...