Vera Therapeutics TRUTAKNA IgA肾病ORIGIN 3终期数据阳性并登NEJM，系9月已披露数据的学术发布，无新增事实

Vera Therapeutics, Inc. (VERA) announced positive final efficacy results from the Phase 3 ORIGIN 3 trial of TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy (IgAN), with the data presented at ASN Kidney Week 2026 and reported in the New England Journal of Medicine.
IgA nephropathy is a chronic kidney disease in which abnormal immune deposits build up in the kidneys, potentially leading to progressive kidney damage, kidney failure, dialysis or transplantation over time.
TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, met the study's primary endpoint of proteinuria reduction at 36 weeks and achieved statistical significance across all prespecified efficacy endpoints in the final analysis. According to the company, the treatment significantly improved kidney function measures, including estimated glomerular filtration rate (eGFR), annualized eGFR slope, and the risk of composite kidney disease progression events.
The study also reported significant reductions in urine protein-to-creatinine ratio, galactose-deficient IgA1, and hematuria, all markers associated with IgA nephropathy activity.
TRUTAKNA was generally well tolerated, with a safety profile comparable to placebo. Adverse events were reported in 75% of patients receiving TRUTAKNA and 78% of patients receiving placebo, while serious adverse events occurred in 7% and 15% of patients, respectively. Infection rates were similar between the treatment and placebo groups, and no clinically relevant hypogammaglobulinemia or opportunistic infections were observed. There were no deaths in the TRUTAKNA group, compared with one death in the placebo group.
TRUTAKNA previously received accelerated FDA approval to reduce proteinuria in adults with IgA nephropathy at risk for disease progression. Based on the ORIGIN 3 results, Vera plans to submit a sBLA to the FDA in the fourth quarter of 2026 in support of full approval, which the company expected could occur in 2027.
TRUTAKNA is administered as a once-weekly, at-home autoinjector and is designed to inhibit BAFF and APRIL, two immune-system proteins believed to play a key role in the development of IgA nephropathy.
VERA has traded between $23.05 and $56.05 over the past year. The stock is currently at $30.67, down 1.70%.
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