Atacicept Shows Sustained eGFR Stabilization in IgAN Patients Over 96 Weeks
核心洞察
Vera Therapeutics' atacicept demonstrated stabilization of kidney function in IgAN (搜索) patients over 96 weeks in the ORIGIN Phase 2b trial.
The study showed significant reductions in Gd-IgA1, hematuria (搜索), and proteinuria (搜索), suggesting disease modification.
Topline results from the Phase 3 ORIGIN 3 trial are expected in Q2 2025, with a planned BLA submission to the FDA later that year.
Vera Therapeutics announced positive long-term data from its ORIGIN Phase 2b trial of atacicept in patients with immunoglobulin A nephropathy (IgAN (搜索)), demonstrating stabilized kidney function over 96 weeks. The data, presented at the American Society of Nephrology Kidney Week 2024 and published in the Journal of the American Society of Nephrology, suggest that atacicept has the potential to modify the disease's natural history and prevent kidney failure.
Jonathan Barratt, MD, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester, stated, "The 96-week results from the ORIGIN Phase 2b study demonstrated sustained and substantial reductions in Gd-IgA1, hematuria (搜索) and proteinuria (搜索) as measured by UPCR with long-term stabilization of eGFR. Converting patients with IgAN (搜索) from an eGFR profile of unrelenting decline to a profile consistent with the general population without kidney disease is a differentiated and compelling finding."
Key Findings from the ORIGIN Phase 2b Trial
Over the 96-week study period, patients treated with atacicept experienced:
- A 66% reduction in galactose-deficient IgA1 (Gd-IgA1).
- Resolution of hematuria in 75% of participants.
- A 52% reduction in proteinuria.
- A mean annualized estimated glomerular filtration rate (eGFR) slope of -0.6 mL/min/1.73m2/year.
The safety profile of atacicept remained consistent with earlier observations, with a 90% completion rate of atacicept treatment.
Implications for IgAN Treatment
The current treatment landscape for IgAN (搜索) primarily involves managing symptoms and slowing disease progression using renin-angiotensin-aldosterone system (RAAS) inhibitors. However, many patients continue to progress to kidney failure, highlighting the need for therapies that target the underlying cause of the disease. Atacicept, a B-cell and plasma cell modulator, aims to address this unmet need by reducing autoantibodies.
Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics, noted, "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 (搜索)."
Ongoing and Future Studies
Vera Therapeutics is planning to initiate the ORIGIN Extend study in Q4 2024 to provide continued access to atacicept for ORIGIN participants. The company anticipates topline results from the Phase 3 ORIGIN 3 trial in Q2 2025, with a planned BLA submission to the U.S. FDA later in the year. Additionally, the PIONEER study is planned for 2025 to evaluate atacicept in expanded IgAN (搜索) populations and other autoimmune glomerular diseases.