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Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025
Globenewswire· 2025-10-14 12:00
Core Insights - Vor Bio announced positive results from a Phase 3 study of telitacicept in primary Sjögren's disease, achieving significant improvements in disease activity compared to placebo [1][2][4] - The study demonstrated a favorable safety profile and sustained efficacy over 48 weeks, indicating potential for telitacicept to be a leading treatment option in this area [2][4] - The company is considering the timing for a global Phase 3 clinical study to expand the treatment's availability [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 [9] - Telitacicept is designed to inhibit key cytokines involved in B cell survival, addressing the underlying causes of autoimmune conditions rather than just managing symptoms [7][9] - The company has previously achieved approval for telitacicept in China for conditions such as systemic lupus erythematosus and rheumatoid arthritis, and is currently conducting a global Phase 3 trial for generalized myasthenia gravis [8] Study Details - The Phase 3 trial was randomized, double-blind, and placebo-controlled, involving 381 patients with active, anti-SSA-positive primary Sjögren's disease [2][3] - Key endpoints included changes in ESSDAI and ESSPRI at multiple time points, with significant improvements noted at both 24 and 48 weeks [3][4] - At week 24, 71.8% of patients receiving telitacicept 160mg achieved a ≥3-point reduction in ESSDAI compared to 19.3% on placebo, with similar results at week 48 [1][4] Disease Context - Primary Sjögren's disease is a chronic autoimmune condition characterized by inflammation and damage to moisture-producing glands, leading to symptoms such as dry eyes and mouth, fatigue, and systemic complications [5][6] - The disease is underdiagnosed, with a significant unmet need for effective therapies, as current treatments primarily focus on symptom management [6] - Telitacicept's dual-target mechanism may provide a novel approach to treating this condition by reducing autoreactive B cells and autoantibody production [7]