Vera Therapeutics Announces 96-week eGFR Stabilization in ORIGIN Phase 2b Study of Atacicept in IgAN in a Late-Breaking Oral Presentation at the American Society of Nephrology Kidney Week 2024

• Long-term improvements observed in the quartet of findings defining disease modification supports atacicept’s potential to prevent kidney failure in patients with IgAN;
• Long-term results from the ORIGIN Phase 2b study were simultaneously published in the Journal of the American Society of Nephrology;
• Company will host an investor call and webcast on Monday October 28 at 8:00 AM ET

BRISBANE, Calif., Oct. 26, 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 data from its ORIGIN Phase 2b trial of atacicept in immunoglobulin A nephropathy (IgAN) that show stabilized kidney function through 96 weeks of long-term follow-up. These data were presented in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024 in San Diego, California, and simultaneously published in a manuscript in the Journal of the American Society of Nephrology.

“The 96-week results from the ORIGIN Phase 2b study demonstrated sustained and substantial reductions in Gd-IgA1, hematuria and proteinuria as measured by UPCR with long-term stabilization of eGFR,” said Jonathan Barratt, MD, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester. “Converting patients with IgAN from an eGFR profile of unrelenting decline to a profile consistent with the general population without kidney disease is a differentiated and compelling finding. Collectively, the data support the potential of atacicept to modify the natural history of the disease and prevent kidney failure during the lifetime of patients with IgAN.”

“We are excited to present these long-term efficacy and safety data from the ORIGIN Phase 2b study, which further demonstrate atacicept’s potential to address the underlying pathogenesis of IgAN. The stabilization of kidney function through two years—the longest duration of data among B cell modulators to date—positions atacicept as a potential best- and first-in-class treatment option for patients with IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We look forward to announcing expected topline results from the Phase 3 ORIGIN 3 trial in Q2 2025, with planned BLA submission to the U.S. FDA later in the year.”

Over 96 weeks, participants treated with atacicept demonstrated a -66% reduction in galactose-deficient IgA1 (Gd-IgA1), resolution of hematuria in 75% of participants, a -52% reduction in proteinuria, and a mean annualized estimated glomerular filtration rate (eGFR) slope of -0.6 mL/min/1.73m2/year. The cumulative generally favorable safety profile of atacicept remained consistent with that observed during the randomized period, with a 90% completion rate of atacicept treatment.

Figure 1. ORIGIN Phase 2b long-term 96-week results with atacicept was consistent with disease-modifying IgAN profile

The Company believes these data support the potential for atacicept to offer long-term, comprehensive IgAN disease modification and provide further confidence in the ongoing pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN.

The Company will host an investor call and webcast to discuss the data update on Monday, October 28, at 8:00 AM ET. The live webcast will be available on the Company’s Investor Calendar at https://ir.veratx.com/news-events/investor-calendar, with the recording and presentation available immediately following the event.

The Kidney Week 2024 presentation and posters are available on the Company’s website at https://ir.veratx.com/news-events/presentations.

Upcoming milestones:

• ORIGIN Extend – plan 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.
• Pivotal ORIGIN 3 trial on track to announce topline results in Q2 2025, with planned BLA submission to the U.S. FDA later in the year
• PIONEER Study – plan to initiate a study in 2025 that will evaluate 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