Vor Bio Announces Publication of China Phase 3 Study of Telitacicept in Systemic Lupus Erythematosus in The New England Journal of Medicine
Trial met primary endpoint achieving statistically significant improvement in disease activity, with 67.1% of patients responding with telitacicept versus 32.7% with placebo
Dual inhibition of BAFF and APRIL validated as a transformative B-cell approach, highlighting telitecicept’s potential as a disease-modifying therapy for systemic lupus erythematosus
BOSTON, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that results from a Phase 3 study in China evaluating telitacicept in systemic lupus erythematosus (SLE) sponsored by its collaborator, RemeGen Co., Ltd., (HKEX: 9995, SHA: 688331), were published in The New England Journal of Medicine (NEJM).
“We are humbled by what these results represent for patients and the scientific community, and by the recognition that comes with their publication in The New England Journal of Medicine, which underscores the global acceptance of the quality and rigor of clinical research emerging from China. For the first time, a therapy in a Phase 3 trial is delivering more than double the clinical response seen with the current standard of care in lupus. These data present a compelling case for potentially broadening telitacicept’s use as a new standard of care worldwide,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. “Lupus has challenged researchers and clinicians for decades. To see a dual BAFF/APRIL approach deliver this level of efficacy, durability, and consistency across multiple indications, while maintaining a favorable safety profile, affirms our belief that telitacicept has the potential to redefine how autoimmune diseases are treated.”
“These data support the central role of B-cells in the pathobiology of lupus. By targeting both BAFF and APRIL, it was possible to achieve excellent clinical results that suggest the effective restoration of immune balance in at least some of the patients. With this mechanism of action, telitacicept could significantly reduce the burden of lupus,” said Ronald van Vollenhoven, M.D., Ph.D., Professor of Rheumatology at Amsterdam University Medical Center. “This approach could represent an important new addition to the therapeutic landscape for lupus.”
The study, conducted at 42 hospitals in China, evaluated telitacicept in 335 patients with active SLE despite standard therapy. The study met its primary endpoint with 67.1% of patients who received telitacicept achieving a modified SLE Responder Index-4 (SRI-4) response compared with 32.7% on placebo (P
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.