Vera Therapeutics to Present ORIGIN Phase 2b Long-term Results at ASN Kidney Week 2024

Vera Therapeutics, Inc., a biotechnology company at an advanced clinical stage, dedicated to transformative treatments for severe immunological diseases, recently announced significant developments related to their lead product candidate, atacicept, intended for treating IgA nephropathy (IgAN). During the American Society of Nephrology (ASN) Kidney Week 2024, held from October 23 to 27 in San Diego, California, Vera Therapeutics will present long-term findings from the ORIGIN Phase 2b clinical trial of atacicept. The presentation will be given by Jonathan Barratt, M.D., Ph.D., F.R.C.P., a noted expert in renal medicine from the University of Leicester, on October 26. Additionally, two poster presentations will provide details on the ORIGIN Phase 3 and ORIGIN Extend trials, delivered by Richard Lafayette, M.D., F.A.C.P., from Stanford University Medical Center.

Furthermore, Vera Therapeutics will host a combined in-person and virtual R&D Day in New York on October 2. This event will feature leading experts, including Jonathan Barratt, Dr. Richard Lafayette, and Brad Rovin, M.D., from Ohio State University Wexner Medical Center, who will discuss the expanded R&D activities for atacicept. The session will include a live Q&A segment following the formal presentations.

Vera Therapeutics' mission is to advance treatments that address the root causes of immunological diseases, aiming to improve the standard of care for patients. Atacicept, their primary product candidate, is a recombinant fusion protein administered subcutaneously once a week. It inhibits both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which are responsible for stimulating B cells and plasma cells to produce autoantibodies involved in diseases such as IgAN and lupus nephritis. The company is also exploring other autoimmune conditions where atacicept may prove beneficial. Additionally, Vera Therapeutics is developing MAU868, a monoclonal antibody targeting the BK virus (BKV), which poses significant risks in kidney transplant scenarios.

In recent developments, the ORIGIN Phase 2b clinical trial of atacicept in treating IgAN met its primary and key secondary endpoints, showing statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR when compared to a placebo over 36 weeks. Safety profiles during the trial were comparable between atacicept and placebo groups. Through 72 weeks, atacicept continued to demonstrate reductions in Gd-IgA1, hematuria, and proteinuria, alongside stabilization of eGFR, reflecting a profile akin to the general population without IgAN.

The FDA has granted atacicept Breakthrough Therapy Designation for treating IgAN, indicating that atacicept may offer substantial improvements over existing therapies based on the Phase 2b trial data. Vera Therapeutics believes that atacicept has the potential to become a best-in-class treatment, targeting B cells and plasma cells to reduce autoantibodies. It has been administered to over 1,500 patients across various indications in clinical studies.

Vera Therapeutics retains global rights for the development and commercialization of both atacicept and MAU868. Their ongoing efforts and recent findings underscore their commitment to addressing significant unmet medical needs in the field of immunological diseases.