Vor Biopharma Inc (NASDAQ:VOR) rose 3.8% in premarket trading Tuesday after its partner RemeGen announced encouraging 48-week Phase 3 results for telitacicept in patients with primary Sjögren’s syndrome.
The China-based trial met its primary endpoint — change from baseline in ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) at week 24 — as well as all secondary endpoints. The 160 mg telitacicept dose produced highly significant results (p<0.0001) compared to placebo.
At week 24, patients on the 160 mg dose saw a mean ESSDAI change of -4.4, compared with -0.6 in the placebo group. This improvement persisted through week 48, with a -4.6 change versus -0.4 for placebo, demonstrating sustained reductions in disease activity.
“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 study evaluated weekly subcutaneous injections of telitacicept at 160 mg, 80 mg, or placebo for 48 weeks. Patient-reported outcomes improved markedly, with 89.1% of patients in the 160 mg group experiencing meaningful symptom relief at week 48, compared to 33.3% in the placebo group.
Telitacicept was well tolerated, showing a safety profile similar to placebo, with most adverse events classified as mild to moderate and no new safety concerns identified.
Vor Bio said it is now assessing the timing for a global Phase 3 trial in primary Sjögren’s disease, aiming to bring this potential therapy to more patients worldwide.
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