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Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study
Dual BLyS/APRIL inhibition with telitacicept led to significant 24h-UPCR reductions, lower progression-risk thresholds, and stable eGFR compared with placebo.
New research shows RemeGen’s telitacicept exhibited efficacy and a favorable safety profile in adults with IgA nephropathy (IgAN) at a high risk of disease progression.1
A 39-week phase 3 multicenter, randomized, double-blind, 2-part study examined telitacicept’s impact on urine protein creatinine ratio (UPCR), CD19+ B-cell count, immunoglobulin levels (IgG, IgA, and IgM), and estimated glomerular filtration rate (eGFR).
A novel fusion protein and B-cell modulating biologic, telitacicept, dually targets and neutralizes B-lymphocyte stimulator (BLyS) and A proliferation-inducing ligand (APRIL), 2 immune-system signalling proteins implicated in the production of pathogenic galactose-deficient IgA1.2
“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,” said Jean-Paul Kress, MD, chief executive officer and chairman of the board at Vor Bio in a statement from the company. “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.”3
In stage A, patients were randomly assigned in a 1:1 ratio to receive subcutaneous telitacicept 240mg or placebo once weekly for 39 weeks, with a primary endpoint of change from baseline in 24-hour UPCR. Other endpoints assessed were kidney function, measured by eGFR, resolution of hematuria, changes in B-cell counts, and serum immunoglobulins.
Investigators reported telitacicept achieved the primary endpoint of reducing proteinuria, with a -58.9% change in 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared with -8.8% for placebo (P <.0001).
Telitacicept also demonstrated substantial proteinuria improvements across additional measures. At week 39, the treatment group showed a 55% reduction in 24h-UPCR. A greater proportion of patients receiving telitacicept achieved thresholds associated with lower progression risk: 61% vs 19.5% achieved 24h-UPCR <0.8 g/g, 42.1% vs 7.5% achieved <0.5 g/g, and 24.5% vs 0.6% achieved <0.3 g/g.
Across secondary endpoints, kidney function remained stable with telitacicept. Investigators reported a stabilized eGFR (-0.010 mL/min/1.73 m²) in the telitacicept group, compared with a decline (-0.77 mL/min/1.73 m²) in the placebo group. The risk of ≥30% eGFR decline was lower among patients receiving telitacicept than in the placebo group (27.0%).
Investigators noted a favorable safety profile. Although treatment-emergent adverse events occurred more frequently with telitacicept (89.3%) than placebo (78.6%), most were mild or moderate. Serious adverse events occurred less often with telitacicept (2.5%) than placebo (8.2%).
The investigational recombinant fusion protein enters a rapidly evolving therapeutic landscape in IgAN, where multiple B-cell–, BAFF-, and APRIL-targeted approaches are under active clinical investigation. These include povetacicept, which is designed to interrupt the upstream biology that drives Gd-IgA1 generation in IgAN and anti-PLA2R autoantibody production in pMN, and sibeprenlimab, which has continued to demonstrate reductions in galactose-deficient immunoglobulin A1 along with a favorable safety profile.
References
Jicheng L, Liu LJ, Wang W. Efficacy and Safety of Telitacicept in Patients with IgAN: Results from Stage A of a Phase 3 Clinical Study. Journal of the American Society of Nephrology.
Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025 | Vor Bio. Vor Bio. Published 2025. Accessed November 18, 2025. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-demonstrates-clinically-meaningful-and
Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China | Vor Bio. Vor Bio. Published 2025. Accessed November 18, 2025. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-reducing-proteinuria
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