Vera Therapeutics Completes Phase 3 Enrollment for Atacicept in IgAN Trial

Vera Therapeutics, Inc., a biotechnology company in the late stages of clinical development, has successfully completed participant enrollment for the primary endpoint in the critical Phase 3 ORIGIN 3 trial of atacicept for patients with IgA nephropathy (IgAN). This accomplishment was achieved ahead of the planned schedule, enrolling 200 participants who will provide crucial data for the 36-week urinary protein-to-creatinine ratio (UPCR) primary efficacy endpoint. This data will support future regulatory submissions for approval. 

Dr. Marshall Fordyce, Founder and CEO of Vera Therapeutics, expressed excitement about reaching this milestone. He acknowledged the dedication of investigators and participants, whose enthusiasm for the clinical program facilitated rapid enrollment. Fordyce highlighted atacicept's potential as a transformative treatment for IgAN, a sentiment supported by positive data from the ORIGIN Phase 2b trial. In this previous trial, patients treated with atacicept showed stable kidney function over 72 weeks and rapid reductions in hematuria, indicating the drug's ability to prevent the need for dialysis. This promising data led to an FDA Breakthrough Therapy Designation for atacicept earlier in the year. The company is also preparing to present long-term 96-week data from the Phase 2b trial in the fourth quarter of 2024. Fordyce believes that atacicept could become one of the first B cell modulators approved for IgAN, providing a new standard of care for this severe disease.

The ORIGIN 3 clinical trial, identified as NCT04716231, is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. It aims to evaluate the safety and efficacy of atacicept in patients with persistent proteinuria and a high risk of disease progression. The trial's primary objectives are to assess the impact of atacicept on proteinuria and the preservation of kidney function compared to a placebo.

Vera Therapeutics is a biotechnology company in the advanced stages of clinical development, focused on creating treatments for serious immunological diseases. Their primary candidate, atacicept, is a fusion protein administered as a subcutaneous injection once a week. It functions by blocking B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are involved in the production of autoantibodies that contribute to autoimmune diseases like IgAN and lupus nephritis. Vera Therapeutics is also developing MAU868, a monoclonal antibody aimed at neutralizing the BK virus (BKV), which poses significant risks in kidney transplant settings. Vera holds all global development and commercial rights for both atacicept and MAU868.

Atacicept is an investigational recombinant fusion protein designed to bind to BAFF and APRIL, cytokines that promote B-cell survival and autoantibody production linked to autoimmune diseases. The Phase 2b ORIGIN trial showed that atacicept met its primary and secondary endpoints with statistically significant reductions in proteinuria and stabilization of estimated glomerular filtration rate (eGFR) compared to a placebo over 36 weeks. The safety profile was comparable between the atacicept and placebo groups. Over 72 weeks, atacicept further demonstrated reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR, indicating a profile similar to that of individuals without IgAN.

With FDA Breakthrough Therapy Designation, atacicept is recognized for its potential to significantly improve clinical outcomes over existing therapies for IgAN. Vera Therapeutics is optimistic about atacicept's best-in-class potential, having been administered to over 1,500 patients across various clinical studies.

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