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Vor Bio (NASDAQ:VOR) stated on Tuesday that its collaborator, RemeGen Co. Ltd., had shared 48-week results from its Phase 3 study conducted in China evaluating telitacicept in primary Sjögren’s disease.
Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs.
Symptoms include dry eyes and mouth, fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system.
Also Read: Vor Bio’s Investigational Drug Scores Phase 3 Win In Autoimmune Kidney Disease Trial
The study met its primary endpoint of change from baseline in ESSDAI at week 24 and all secondary endpoints, with the telitacicept 160mg dose achieving highly significant p-values for every endpoint at both week 24 and 48 compared to placebo.
The results will be presented at the American College of Rheumatology Convergence 2025.
Three hundred eighty-one patients were randomized to receive weekly subcutaneous injections of telitacicept 160mg, telitacicept 80mg, or placebo for 48 weeks, in addition to standard therapy.
The primary endpoint of the study was the 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 at 24 and 48 weeks.
Around 71.8% of patients receiving telitacicept 160mg achieved ≥3-point ESSDAI reduction vs. 19.3% on placebo at 24 weeks.
Sustained efficacy and favorable safety profile through 48 weeks support potential best-in-disease profile in primary Sjögren’s disease.
Telitacicept demonstrated a favorable safety profile comparable to that of the placebo and consistent with prior studies across other autoimmune indications, including systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, and IgA nephropathy.
No new safety signals were observed. Most adverse events were mild to moderate in severity.
In August, Novartis AG (NYSE:NVS) released topline data from two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2, evaluating ianalumab (VAY736) in adults with active Sjögren's disease.
Both trials met the primary endpoint of demonstrating statistically significant improvements in disease activity.
Price Action: VOR stock is down 8.18% at $29.65 at the last check on Tuesday.
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