Vera Therapeutics Shows 72-Week eGFR and Hematuria Benefits of Atacicept in IgAN at ERA Congress

Vera Therapeutics, Inc., a late-stage biotechnology company, has presented promising data from its Phase 2b ORIGIN trial on atacicept, targeting immunoglobulin A nephropathy (IgAN). The findings were shared at the 61st European Renal Association Congress (ERA24) in Stockholm. Atacicept demonstrated stabilization of kidney function over 72 weeks and rapid improvements in hematuria, outperforming placebo in a significant number of patients.

According to Marshall Fordyce, M.D., CEO of Vera Therapeutics, this is the first time that 72-week data in this field have illustrated stable kidney function throughout treatment. The data showed that atacicept induced the resolution of hematuria much more effectively than placebo, with notable improvements as early as four weeks into treatment. These results suggest that atacicept could offer substantial disease modification benefits for patients with IgAN, particularly those suffering from acute kidney inflammation. The company plans to unveil complete 96-week data from the Phase 2b ORIGIN trial in the fourth quarter of the year.

The trial demonstrated that participants receiving atacicept maintained stable estimated glomerular filtration rates (eGFR) and showed consistent reductions in Gd-IgA1, hematuria, and urine protein-to-creatinine ratio (UPCR). Similar positive outcomes were observed in participants who switched from placebo to atacicept after the initial 36 weeks. The safety profile of atacicept was consistent, with a 91% retention rate at 72 weeks, supporting the potential for long-term disease modification in IgAN.

The ERA24 Congress recognized the 72-week abstract as a top-ranked submission. Dr. Richard Lafayette of Stanford University presented the findings titled "Phase 2b ORIGIN Study Open Label Extension with Atacicept in Patients with IgA Nephropathy and Persistent Proteinuria: Week 72 Interim Analysis." Dr. Jürgen Floege from the University of Aachen also presented a post-hoc analysis of the 36-week data, highlighting significant hematuria resolution in participants treated with atacicept compared to those given a placebo.

The Phase 2b ORIGIN trial was a global, multicenter, randomized, double-blind, placebo-controlled study involving 116 patients with IgAN who continued to exhibit proteinuria despite stable renin-angiotensin-aldosterone system inhibitor (RAASi) therapy. The trial assessed three doses of atacicept versus placebo. After the initial 36-week treatment phase, all participants were offered an additional 60 weeks of open-label atacicept at 150 mg.

The primary outcome of the study was the change in proteinuria measured by UPCR at week 24, with a key secondary outcome at week 36. Additional exploratory endpoints included UPCR changes at other intervals, eGFR changes, and various serum markers. The trial met its primary and key secondary outcomes, showing significant reductions in proteinuria and stable eGFR compared to placebo over 36 weeks, with comparable safety profiles between the groups.

Moving forward, the pivotal Phase 3 ORIGIN 3 trial, a global, randomized, double-blind, placebo-controlled study, continues to evaluate the efficacy and safety of atacicept 150 mg in IgAN patients. The trial includes a 104-week double-blind treatment period, followed by a 52-week open-label extension and 26 weeks of follow-up. The primary endpoint is the change in proteinuria at week 36, with secondary endpoints including the rate of change in eGFR up to week 104.

IgAN, or Berger’s disease, is a severe autoimmune disorder leading to progressive kidney damage and potential kidney failure in up to 50% of patients. Atacicept, a recombinant fusion protein, targets specific cytokines to reduce autoantibodies associated with IgAN and lupus nephritis. Vera Therapeutics aims to establish atacicept as a leading treatment for these conditions and is also exploring its use in other autoimmune diseases.

Vera Therapeutics is committed to advancing therapies that address the root causes of immunological diseases, aiming to improve patient outcomes significantly. The company also develops MAU868, a monoclonal antibody for neutralizing BK virus infections, particularly in kidney transplant settings. Vera retains global rights to both atacicept and MAU868, driving innovation in immunological disease treatment.