Vor Bio Announces Publication of China Phase 3 Study of Telitacicept in Systemic Lupus Erythematosus in The New England Journal of Medicine

Core Insights - Vor Bio announced significant results from a Phase 3 study of telitacicept for systemic lupus erythematosus (SLE), achieving a primary endpoint with 67.1% of patients responding compared to 32.7% with placebo [1][2] - The dual inhibition of BAFF and APRIL is validated as a transformative approach for B-cell targeting, indicating telitacicept's potential as a disease-modifying therapy for SLE [1][2] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, particularly through the development of telitacicept [8] - The company aims to advance telitacicept through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions globally [8] Study Details - The Phase 3 study was conducted at 42 hospitals in China, involving 335 patients with active SLE despite standard therapy [2] - The study met its primary endpoint with a statistically significant improvement in disease activity, as measured by the modified SLE Responder Index-4 (SRI-4) response at week 52 [1][2] Efficacy and Safety Findings - Telitacicept demonstrated improvements across multiple secondary measures, including a 70.1% reduction in SELENA-SLEDAI score compared to 40.5% for placebo [4] - The safety profile of telitacicept was consistent with previous studies, with serious adverse events occurring less frequently compared to placebo [3] Mechanism of Action - Telitacicept is designed to selectively inhibit BAFF and APRIL, two cytokines essential for B cell and plasma cell survival, thereby reducing autoreactive B cells and autoantibody production [6] - This dual-target mechanism is believed to restore immune balance in patients, potentially reducing the burden of lupus [2][6] Regulatory Status - Telitacicept is already approved in China for SLE, rheumatoid arthritis, and generalized myasthenia gravis, with ongoing global Phase 3 trials to support potential approval in the United States, Europe, and Japan [7]