Vor Bio Partner RemeGen's Telitacicept Trial in IgA Nephropathy Meets Primary Goal

Vor Bio's partner RemeGen reported that a phase 3 trial of telitacicept in IgA nephropathy in China met its primary endpoint. The trial enrolled 318 adult IgAN patients who had received standard treatment and were randomly assigned to receive telitacicept or placebo. The primary endpoint was met, indicating a potential new treatment option for IgA nephropathy.

Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, has reported that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), has achieved the primary endpoint in Stage A of a Phase 3 clinical study evaluating telitacicept in adults with IgA nephropathy (IgAN). The trial enrolled 318 adult IgAN patients who had received standard therapy and were randomly assigned to receive telitacicept or placebo.

The primary endpoint of reducing proteinuria was met, demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo (p0.0001). This result underscores telitacicept’s potential as a disease-modifying treatment for IgAN, where UPCR is a well-established, objective endpoint for regulatory approval.

Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board of Vor Bio, stated, “Telitacicept continues to demonstrate consistent, disease-modifying activity across autoimmune conditions, from myasthenia gravis to Sjögren’s disease and now IgA nephropathy. In IgAN, these results underscore the strength of the telitacicept dataset and its comparability to global benchmarks. By directly targeting the upstream drivers of IgAN and stopping the downstream signaling that fuels disease progression, telitacicept has the potential to modify the disease at its core, potentially leading to deeper, more durable responses and long-term kidney preservation for patients.”

The Phase 3 trial was well-designed, involving a multicenter, randomized, double-blind, placebo-controlled study. This robust study design strengthens the credibility of the results, which are anticipated to be presented at an upcoming medical conference.

RemeGen plans to submit a Biologics License Application (BLA) to Chinese regulators. If approved, IgAN would become telitacicept’s fifth approved indication in China, further validating its multi-indication potential and strengthening Vor Bio's position in the autoimmune disease space.

The results of this trial reinforce telitacicept’s potential across multiple autoimmune diseases, including IgA nephropathy, myasthenia gravis, and Sjögren’s disease.

References:
[1] https://www.nasdaq.com/press-release/telitacicept-achieved-primary-endpoint-phase-3-clinical-study-iga-nephropathy-2025-08
[2] https://www.stocktitan.net/news/VOR/telitacicept-achieved-primary-endpoint-in-phase-3-clinical-study-for-y5pl5qiv9htw.html