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Investing.com -- Vor Biopharma Inc (NASDAQ:VOR) stock gained 3.8% in premarket trading Tuesday after its collaborator RemeGen reported positive 48-week results from a Phase 3 study of telitacicept in primary Sjögren’s disease.
The China-based Phase 3 trial met its primary endpoint of change from baseline in ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) at week 24, as well as all secondary endpoints. The telitacicept 160mg dose achieved highly significant p values (p<0.0001) compared to placebo.
At week 24, patients receiving the 160mg dose showed a mean change in ESSDAI of -4.4 compared to -0.6 for placebo. This improvement was maintained through week 48, with the 160mg dose group showing a -4.6 change versus -0.4 for placebo, demonstrating durable disease activity reduction.
"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," said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio.
The 381-patient randomized, double-blind, placebo-controlled trial evaluated weekly subcutaneous injections of telitacicept at 160mg, 80mg, or placebo for 48 weeks. The drug also showed significant improvements in patient-reported outcomes, with 89.1% of patients in the 160mg group achieving meaningful symptom reduction at week 48 compared to 33.3% for placebo.
Telitacicept demonstrated a favorable safety profile comparable to placebo, with most adverse events being mild to moderate in severity and no new safety signals observed.
Based on these results, Vor Bio is evaluating the timing of a global Phase 3 clinical study in primary Sjögren’s disease, which represents a significant opportunity to expand telitacicept’s benefits to patients worldwide.
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