Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy
Results reinforce telitacicept’s potential across multiple autoimmune diseases
Data anticipated to be presented at an upcoming medical conference
Excerpt from the Press Release:
CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) — Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN). Details of the study results are planned to be presented at an upcoming medical conference.
“Telitacicept continues to demonstrate consistent, disease-modifying activity across autoimmune conditions, from myasthenia gravis to Sjögren’s disease and now IgA nephropathy,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. “In IgAN, where UPCR is a well-established, objective endpoint for regulatory approval, these results underscore the strength of the telitacicept dataset and its comparability to global benchmarks. By directly targeting the upstream drivers of IgAN and stopping the downstream signaling that fuels disease progression, telitacicept has the potential to modify the disease at its core, potentially leading to deeper, more durable responses and long-term kidney preservation for patients. Taken together, these data reinforce our conviction that telitacicept is a pipeline-in-a-product with the potential to deliver a best-in-class profile across multiple autoimmune diseases.”
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in China that enrolled 318 adult IgAN patients who had received standard therapy. In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo (p<0.0001).
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