Vera Therapeutics Announces Long-Term Data Demonstrating Atacicept’s Potential to Prevent Kidney Failure in IgAN Patients
Vera Therapeutics, a leading biotechnology company focused on developing innovative treatments for serious immunological diseases, has unveiled encouraging long-term results from its ORIGIN Phase 2b trial. The data show that atacicept, a B-cell modulator, can stabilize kidney function in patients with immunoglobulin A nephropathy (IgAN), a chronic kidney disease. These findings suggest a potential for atacicept to prevent kidney failure in these individuals.
The data, presented at the American Society of Nephrology Kidney Week 2024 and simultaneously published in the Journal of the American Society of Nephrology, highlight the sustained benefits of atacicept over a two-year period. Participants in the trial who received atacicept demonstrated significant improvements in various key markers associated with IgAN progression:
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Reduced Galactose-Deficient IgA1 (Gd-IgA1):
Ataccept treatment led to a remarkable -66% reduction in Gd-IgA1, a specific type of IgA antibody implicated in IgAN. This reduction was sustained over the 96-week trial period.*
Improved Hematuria:
A significant 75% of participants experienced resolution of hematuria, a hallmark of IgAN characterized by blood in the urine.*
Reduced Proteinuria:
Ataccept treatment resulted in a substantial -52% reduction in proteinuria, a measure of protein in the urine that indicates kidney damage.*
Stabilized eGFR:
Notably, the study observed a mean annualized estimated glomerular filtration rate (eGFR) slope of -0.6 mL/min/1.73m2/year. This stabilization of eGFR, a key indicator of kidney function, contrasts with the typical decline observed in IgAN patients and suggests that atacicept could potentially halt the progression of kidney disease.The safety profile of atacicept remained favorable throughout the study, with a 90% completion rate of atacicept treatment, further reinforcing its potential as a safe and effective treatment option.
Ataccept’s Potential as a Disease-Modifying Treatment for IgAN
These long-term data, particularly the stabilization of eGFR, emphasize atacicept’s potential to modify the course of IgAN. This disease-modifying capability sets it apart from other therapies, which primarily focus on managing symptoms and slowing down the disease progression. These findings, coupled with atacicept’s favorable safety profile, make it a promising candidate for a best-in-class treatment for IgAN.
Future Milestones and Ongoing Research
Vera Therapeutics is actively working to further explore and validate atacicept’s potential. The company is currently conducting the pivotal Phase 3 ORIGIN 3 trial in IgAN, with topline results expected in the second quarter of 2025. Additionally, Vera plans to initiate the ORIGIN Extend study in the fourth quarter of 2024, providing extended access to atacicept for participants of the ORIGIN trial. This will allow the company to capture longer-term data and prepare for potential commercial availability.
Vera is also initiating the PIONEER Study in 2025. This study will evaluate the efficacy and safety of atacicept in a wider range of IgAN populations, including those with lower kidney function, different levels of proteinuria, and IgAN recurrence after kidney transplant. The PIONEER study will also explore the potential of atacicept for other autoimmune glomerular diseases.
The long-term data from the ORIGIN Phase 2b trial, coupled with Vera’s ongoing research efforts, provide compelling evidence for atacicept’s potential to significantly impact the treatment landscape for IgAN patients. The company’s dedication to advancing this novel therapy holds immense promise for improving the lives of individuals battling this chronic kidney disease.
