Vera Therapeutics Reports 96-week eGFR Stabilization in Phase 2b Atacicept Study for IgAN at ASN Kidney Week 2024

Vera Therapeutics, Inc., a biotechnology firm in advanced clinical stages, has shared promising long-term data from its ORIGIN Phase 2b trial for the drug atacicept, aimed at treating immunoglobulin A nephropathy (IgAN). Conducted for 96 weeks, the trial demonstrated that atacicept effectively stabilized kidney function, a significant achievement given the disease's typically progressive nature. These findings were divulged at the American Society of Nephrology Kidney Week 2024 in San Diego and published in the Journal of the American Society of Nephrology.

Dr. Jonathan Barratt from the University of Leicester highlighted the trial's outcomes, noting that the data showed substantial and sustained reductions in Gd-IgA1, hematuria, and proteinuria, coupled with long-term stabilization of estimated glomerular filtration rate (eGFR). He emphasized the transformative potential of atacicept in altering the disease's natural course and preventing kidney failure in IgAN patients.

Marshall Fordyce, Founder and CEO of Vera Therapeutics, expressed enthusiasm about the results, underscoring the drug's capability to address IgAN's underlying causes. He noted that the drug's efficacy over two years marks it as a potential leading treatment option for IgAN. He also announced plans to release topline results from the Phase 3 ORIGIN 3 trial in the second quarter of 2025, with a Biologics License Application (BLA) submission to the U.S. FDA anticipated later that year.

The ORIGIN Phase 2b study showed that atacicept led to a 66% reduction in galactose-deficient IgA1 (Gd-IgA1), 75% resolution of hematuria, a 52% decrease in proteinuria, and a mean eGFR slope of -0.6 mL/min/1.73m2/year. The safety profile of atacicept was consistent and favorable throughout the trial, with a high treatment completion rate of 90%.

The company believes these long-term results highlight atacicept’s potential for comprehensive disease modification in IgAN. Vera Therapeutics plans to initiate the ORIGIN Extend study in the fourth quarter of 2024, which will provide further access to atacicept, capturing extended data prior to its commercial availability. The pivotal ORIGIN 3 trial remains on track to report topline results in mid-2025.

Furthermore, Vera Therapeutics is planning the PIONEER Study in 2025, aimed at evaluating the safety and efficacy of atacicept in broader IgAN populations. This includes adults with varying levels of kidney function and proteinuria, adolescents at high risk of disease progression, and patients with IgA vasculitis nephritis. The study will also expand to other autoimmune glomerular diseases, such as primary membranous nephropathy and minimal change disease.

The ORIGIN Phase 2b clinical trial was a global, double-blind, placebo-controlled study involving 116 patients with persistent proteinuria despite being on a stable regimen of renin-angiotensin-aldosterone system inhibitors. The trial met its primary endpoint, showing significant proteinuria reductions and eGFR stabilization, with a safety profile comparable to the placebo.

Atacicept is a recombinant fusion protein designed to bind and inhibit the cytokines BAFF and APRIL, which are involved in B-cell survival and autoantibody production in autoimmune diseases like IgAN and lupus nephritis. The drug has received FDA Breakthrough Therapy Designation, indicating its potential to offer significant improvements over existing therapies for IgAN.

Vera Therapeutics is dedicated to developing treatments for serious immunological diseases. The company’s lead candidate, atacicept, has shown promise in clinical studies and is being further evaluated for its potential to modify the natural progression of IgAN and other autoimmune conditions. Vera also retains global rights to MAU868, another investigational drug aimed at neutralizing BK virus infections, particularly in kidney transplant patients.