Atacicept

BRISBANE, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it will host an in-person and virtual R&D Day in New York, NY at 8:00 AM ET on Wednesday, October 2, 2024. To register, click here. The event will feature Jonathan Barratt, MD, PhD, FRCP (University of Leicester), Richard Lafayette, MD, FACP (Stanford University Medical Center), and Brad Rovin, MD (Ohio State University Wexner Medical Center), who will join the company’s management team to discuss Vera’s expanded atacicept R&D activities outside of the ORIGIN Phase 2b and Phase 3 clinical program. This event will be held in advance of the anticipated 96-week data from the Phase 2b ORIGIN study of atacicept in immunoglobulin A nephropathy (IgAN), which will be presented at an upcoming medical congress in Q4 2024. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. A live question and answer session will follow the formal presentation. About Jonathan Barratt, MD, PhD, FRCPDr. Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester. His research is focused on a bench-to-bedside approach to improving the understanding of the pathogenesis of IgAN, a common global cause of kidney failure. Dr. Barratt is the IgAN Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases (RaDaR), and a member of the steering committee for the International IgAN Network. He works closely with pharmaceutical companies interested in new treatments for IgAN, is Chief Investigator for a number of international randomized controlled Phase 2 and 3 clinical trials in IgAN, and was a member of the U.S. Food and Drug Administration and American Society of Nephrology Kidney Health Initiative: Identifying Surrogate Endpoints for Clinical Trials in IgAN Workgroup. About Richard Lafayette, MD, FACPDr. Lafayette is a Professor of Medicine (Nephrology) and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center. Dr. Lafayette completed his medical education at New York Medical College and went on to complete his residency at the Long Island Jewish Medical Center, and his fellowship at Stanford University School of Medicine. Dr. Lafayette is board-certified in Internal Medicine and Nephrology. Dr. Lafayette served as the Associate Chair of the Stanford University Department of Medicine from 2002–2007, the Clinical Chief of Nephrology at Stanford University from 1999–2012, and currently serves as the Director of the Stanford Glomerular Disease Center since 2010. Dr. Lafayette was honored in America’s Top Doctors, Best Doctors from 2004–2018, and received America’s Top Doctors Award, Castle Connolly Medical Ltd. from 2014–2022. Dr. Lafayette has been part of the following boards and professional organizations: Editorial Board, Kidney News, American Society of Nephrology (2010–2021) Member, Glomerular Disease Advisory Committee, American Society of Nephrology (2013–2017) Member (ex-officio), Communications Committee, American Society of Nephrology (2015–Present). About Brad Rovin, MD, FACP, FASNDr. Brad H. Rovin is the Lee A. Hebert Professor of Nephrology. Dr. Rovin received his Bachelor of Science in Chemical Engineering from Northwestern University in Evanston Illinois and his Doctor of Medicine from the University of Illinois Medical School in Chicago, Illinois. He completed a residency in Internal Medicine at Barnes Hospital in St. Louis Missouri, and a Fellowship in Nephrology at Washington University School of Medicine, St. Louis. He joined the Ohio State University College of Medicine Faculty in 1990, became Director of the Division of Nephrology in 2004, and served as Vice Chairman of Medicine for Research from 2009-2019. In 2019 he became the Medical Director of the Ohio State University Center for Clinical Research Management. Dr. Rovin has had several leadership roles in the American Society of Nephrology, including running the Glomerular Diseases Pre-Course and Co-Editing NephSAP-Glomerular Diseases, a continuing education program of the Society. Most recently, he was appointed Deputy Editor of Kidney International, the flagship journal of the International Society of Nephrology. He is also the Co-Chair for glomerular disease guideline development for the Kidney Disease Improving Global Outcomes effort. Dr. Rovin’s laboratory studies the immunopathogenesis of glomerular and autoimmune diseases. He is heavily involved in clinical trial development and design for investigator-initiated and industry-sponsored trials. He is a founding member of NephroNet, a grass-roots nephrology clinical trial organization, and the Lupus Nephritis Clinical Trials Network. He is and has been the Principal Investigator on several trials of novel therapeutics for glomerular diseases. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com. About AtaciceptAtacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 72 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s anticipated presentations of clinical trial data, and Vera’s product candidates, strategy, and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expanded,” “substantial,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com