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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), reported positive 48-week results from its Phase 3 study conducted in China evaluating telitacicept in primary Sjögren's disease. The study met its primary endpoint of change from baseline in ESSDAI at week 24, as well as all secondary endpoints, with the telitacicept 160mg dose achieving highly significant p values (p<0.0001) for every endpoint at week 24 and 48 compared to placebo. The results will be presented in the late-breaking poster session at the American College of Rheumatology (ACR) Convergence 2025 on October 28, 2025 from 10:30am to 12:30pm CT in Chicago, Illinois.
"With today's Phase 3 results in primary Sjögren's disease, we are thrilled to announce that telitacicept is demonstrating disease-modifying potential in a condition that has long lacked any approved treatment. We believe these are clear data which can help pave a path towards a brighter future for this deserving community. The consistency of benefit through 48 weeks, together with a reassuring safety profile, supports telitacicept's potential to become the first treatment that addresses the root biology of Sjögren's disease rather than managing symptoms alone," said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. "Based on these promising results, we are evaluating the timing of a global Phase 3 clinical study in primary Sjögren's disease, which represents a significant opportunity to expand into and bring telitacicept's benefits to patients worldwide."
"Primary Sjögren's disease represents a substantial unmet need in rheumatology, with patients facing years of fatigue, pain, and systemic complications without a truly effective therapy," said Ronald van Vollenhoven, M.D., Ph.D., Professor of Rheumatology at Amsterdam University Medical Center. "I am impressed how these data show that dual BAFF/APRIL inhibition with telitacicept could offer a clear impact on both disease activity and patient-reported outcomes."
The China Phase 3 trial was a randomized, double-blind, placebo-controlled trial in patients with active, anti-SSA-positive primary Sjögren's disease. A total of 381 patients were randomized to receive weekly subcutaneous injections of telitacicept 160mg, telitacicept 80mg, or placebo for 48 weeks, in addition to standard therapy. During weeks 24-48, participants with inadequate response to treatment in the placebo group could switch to telitacicept 160mg or telitacicept 80mg at a ratio of 1:1 under blind conditions.
The primary endpoint of the study was change from baseline in ESSDAI at week 24, with secondary endpoints including changes in ESSDAI and ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index) at 12, 24, 36, and 48 weeks, as well as the proportion of patients achieving clinically meaningful improvements (≥3-point decrease in ESSDAI and achievement of low disease activity [ESSDAI <5]) at 24 and 48 weeks.
Posted In: VOR
