Vera Therapeutics Announces Expanded Atacicept Development Program In Multiple Autoimmune Kidney Diseases

• PIONEER study expands the investigation of atacicept into a broad definition of IgA nephropathy and into multiple autoimmune glomerular diseases, supported by the disease-modifying potential of BAFF/APRIL dual inhibition;
• Multiple regulatory and clinical milestones expected over the next 18 months;
• Announcements made at Vera’s R&D Day in New York, where the company’s management team was joined by academic leaders Jonathan Barratt, Richard Lafayette, and Brad Rovin

BRISBANE, Calif., Oct. 02, 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 expansion of its development pipeline for its lead asset, atacicept. This program is expected to build on the positive data reported to date from the ongoing ORIGIN Phase 2b and 3 clinical program developing atacicept to treat patients with IgAN, by extending into a broader population of IgAN and other autoimmune kidney indications.

“Based on the positive clinical data announced over the past year, we have a greater understanding of atacicept’s disease-modifying mechanism of action and potential to be a best-in-class treatment option for patients with IgAN. We’re committed to providing long-term access to atacicept for all ORIGIN participants, and the PIONEER study will expand that opportunity to a significantly greater number of patients with IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We believe that B cell modulation through BAFF/APRIL dual inhibition has the potential to transform the treatment landscape for other autoimmune diseases, including autoimmune forms of primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease.”

“We view this expansion of our pipeline as highly complementary to our lead program in IgAN. As such, we remain focused on completing the pivotal clinical program for atacicept in IgAN. We look forward to keeping everyone apprised of our progress, as we have a number of significant milestones planned across our pipeline,” concluded Dr. Fordyce.

• ORIGIN Extend – The company plans to initiate a study in Q4 2024 that will provide ORIGIN participants with extended access to atacicept prior to commercial availability in their region, as well as an opportunity to capture longer-term data.
• PIONEER Study – In 2025, the company plans to initiate a study evaluating the efficacy and safety of atacicept in:
  • Expanded IgAN populations – The first set of cohorts will include adults with low kidney function (eGFR 20 to