Vor Bio Doses First Patient in Global Phase 3 UPSTREAM SjD Registrational Trial of Telitacicept in Primary Sjögren's Disease

Core Insights - Vor Bio has initiated the dosing of the first patient in the global Phase 3 UPSTREAM SjD trial for telitacicept, targeting adult patients with active primary Sjögren's disease [1][2] - Telitacicept is the only BAFF/APRIL inhibitor in Phase 3 development for Sjögren's disease, which currently lacks approved disease-modifying therapies [2][9] - The trial aims to enroll approximately 250 adult patients and will assess the efficacy and safety of telitacicept compared to placebo, with a primary endpoint focused on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48 [2][3] Company Overview - Vor Bio is advancing global development programs for autoimmune diseases, including ongoing trials for generalized myasthenia gravis (gMG) and Sjögren's disease to support potential regulatory approvals in the U.S., Europe, and Japan [7] - Telitacicept is already approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG), with additional regulatory filings for primary Sjögren's disease and IgA nephropathy underway [6] Disease Context - Sjögren's disease is a chronic autoimmune condition characterized by overactive B cells that damage moisture-producing glands, leading to symptoms such as dry eyes and mouth, fatigue, and systemic complications [3][4] - The disease is often underdiagnosed, with about half of the cases unrecognized, and predominantly affects women [4]