Vor Bio Announces Publication of Interim Analysis of TELIGAN, a China Phase 3 Trial of Telitacicept in IgA Nephropathy, in The New England Journal of Medicine

Interim analysis demonstrated a 55.0% relative reduction in proteinuria versus placebo at 39 weeks with eGFR remaining stable through treatment 

Results further support the potential for telitacicept to become a best-in-class dual BAFF/APRIL therapy across autoimmune diseases

BOSTON, May 14, 2026 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that results from the Phase 3 TELIGAN trial evaluating telitacicept in IgA nephropathy in China sponsored by its collaborator, RemeGen Co., Ltd., (HKEX: 9995, SHA: 688331), were published in The New England Journal of Medicine (NEJM).

“We are honored to see the TELIGAN interim analysis published in The New England Journal of Medicine, which we believe speaks to the rigor of the trial and adds to the growing body of evidence supporting the potential of telitacicept across autoimmune diseases,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. “In IgA nephropathy, telitacicept demonstrated substantial reductions in proteinuria together with encouraging preservation of kidney function, with eGFR remaining largely stable through 39 weeks while declining in the placebo arm. We believe these results are encouraging in the context of the evolving treatment landscape for IgA nephropathy. More broadly, as data continue to emerge across multiple B-cell mediated diseases, we believe telitacicept has the potential to become a best-in-class dual BAFF/APRIL therapy capable of delivering meaningful benefit for patients globally.”

The publication reports results from a prespecified interim analysis of the ongoing Phase 3 TELIGAN trial, a multicenter, randomized, double-blind, placebo-controlled trial conducted at 72 sites in China evaluating telitacicept in adults with biopsy-proven IgA nephropathy and persistent proteinuria despite optimized supportive care.

The study met its primary endpoint, demonstrating a statistically significant reduction in proteinuria at week 39. Patients treated with telitacicept achieved a 58.9% reduction from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR), compared with an 8.8% reduction for placebo, representing a 55.0% relative difference between groups (p<0.001). Treatment effects emerged as early as week 4, with separation from placebo widening through week 39.

Additional findings from the interim analysis included:

• Kidney function preservation: Estimated glomerular filtration rate (eGFR) remained stable with telitacicept, with a mean percentage change from baseline of -1.0% compared with -7.7% for placebo at week 39.
• Reduced risk of kidney function decline: A confirmed decline in eGFR of ≥30% occurred in 6.3% of telitacicept-treated patients compared with 27.0% of placebo-treated patients.
• Proteinuria response: At week 39, 61.0% of telitacicept-treated patients achieved a UPCR below 0.8 compared with 19.5% of placebo-treated patients.
• Broadly consistent activity across subgroups: Reductions in proteinuria were observed consistently across prespecified patient subgroups, including baseline kidney function, proteinuria level, and use of SGLT2 inhibitors.
• Pharmacodynamic activity: Telitacicept treatment was associated with reductions in circulating CD19+ B cells and serum immunoglobulin levels, including a 60.6% mean reduction in serum IgA levels.
  
  

Safety findings were generally consistent with previous studies of telitacicept. Most adverse events were mild to moderate in severity. Serious adverse events occurred less frequently with telitacicept than placebo (2.5% vs. 8.2%). The most common adverse events associated with telitacicept included upper respiratory tract infection, injection-site reactions, and reductions in immunoglobulin levels.

About Telitacicept
Telitacicept is a novel recombinant fusion protein designed to treat autoimmune diseases through dual inhibition of BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology.

Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). Additional regulatory filings in China are underway, including biologics license applications for primary Sjögren’s disease (SjD) and IgA nephropathy (IgAN).

Vor Bio is advancing telitacicept in global Phase 3 trials in gMG and SjD to support potential regulatory approvals in the United States, Europe, and Japan.

About IgA Nephropathy
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and a leading cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD). It is characterized by IgA-containing immune complex deposition in the kidney, leading to inflammation, proteinuria, hypertension, and progressive loss of renal function. Up to 40% of patients progress to ESRD within 20 years of diagnosis, underscoring the significant unmet need for effective therapies. Current treatment approaches, including optimized blood pressure control, renin-angiotensin system blockade, and SGLT2 inhibitors, primarily slow disease progression but do not address the underlying immunopathology.

The prevailing scientific consensus is that overproduction of galactose-deficient IgA1 (Gd-IgA1) is a central driver of IgAN. BAFF and APRIL, two cytokines critical to B-cell survival and function, promote the production of Gd-IgA1 and its pathogenic antibodies.

About Vor Bio
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding the potential for telitacicept to become a best-in-class dual BAFF/APRIL therapy across autoimmune diseases and to deliver meaningful benefit for patients globally; Vor Bio’s development and commercialization plans for telitacicept; and other statements that are not historical fact.

Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including the data for our product candidates may not be sufficient for obtaining regulatory approval to commercialize products; we may not be able to execute our business plans, including meeting our planned clinical and regulatory milestones and timelines, and possible limitations of financial and other resources. The results of the clinical trial described in this press release are based on information reported by RemeGen; Vor Bio has not independently verified this data. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission.

Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.

Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com

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