Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China

Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile

Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints

Data presented as late-breaking oral presentation at American Society of Nephrology’s Kidney Week 2025

BOSTON, Nov. 08, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that the primary endpoint was achieved in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN). In addition, statistically significant benefits were achieved across all secondary endpoints in the study, which was conducted by RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), Vor Bio’s collaborator.

“Telitacicept delivered statistically significant deep, sustained, and clinically meaningful reductions in proteinuria with stabilization of kidney function and a favorable safety profile. An objective endpoint like 24h-UPCR validates the therapeutic effect of dual BAFF/APRIL inhibition. These findings, alongside the strong pharmacodynamic evidence of telitacicept’s dual B-cell pathway inhibition, demonstrate its potential to deliver disease-modifying effects in IgAN,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. “With this Phase 3 success in IgAN, telitacicept has provided additional clinical evidence supporting its mechanism in yet another indication, reinforcing our confidence in its potential as a foundational therapy for B-cell mediated diseases.”

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in China that enrolled 318 adult patients with IgAN at high risk of progression who had received stable standard therapy. Patients were randomized (1:1) to telitacicept (240 mg) or placebo, subcutaneously once weekly.

Primary Endpoint Achieved
In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a significant reduction in 24h-UPCRvs. Placebo at 39 weeks compared to placebo (-58.9% vs. -8.8%, p<0.0001), 24h-UPCR is an objective and internally recognized regulatory marker for assessing disease activity in IgAN.