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Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN
Globenewswire· 2025-04-03 12:00
Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Enrollment and Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - Participants are randomized to receive either atacicept 150 mg or placebo via self-administered weekly subcutaneous injections for a 104-week double-blind period, followed by a 52-week open-label extension [2] Efficacy and Safety Data - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, with a key secondary endpoint assessing kidney function via estimated glomerular filtration rate (eGFR) over 104 weeks [3] - The Phase 2b ORIGIN trial demonstrated significant reductions in proteinuria and stabilization of eGFR, supporting the efficacy of atacicept [6] Future Plans and Market Position - The company plans to submit a BLA for atacicept in the second half of 2025, with a potential commercial launch in 2026 [2][8] - Vera Therapeutics retains all global developmental and commercial rights to atacicept and is also developing MAU868, a monoclonal antibody targeting BK virus [9]
Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN
Newsfilter· 2025-04-03 12:00
Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [9] - Atacicept is a recombinant fusion protein that targets B-cell activating factors, aiming to reduce autoantibody production associated with autoimmune diseases like IgAN and lupus nephritis [5][9] - The company is also developing MAU868, a monoclonal antibody for BK virus infections, and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [9] Clinical Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, while the key secondary endpoint assesses kidney function via estimated glomerular filtration rate (eGFR) through 104 weeks [3] - The ORIGIN Phase 2b trial previously demonstrated significant reductions in proteinuria and stabilization of kidney function, reinforcing the potential of atacicept as a best-in-class therapy for IgAN [6]