Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva Pharmaceutical Industries has reported positive topline results from its ongoing Phase 2a study of TEV-408, an investigational anti-interleukin-15 monoclonal antibody, in adults with coeliac disease. The randomised, placebo-controlled study met its primary endpoint at week eight, demonstrating statistically significant prevention of gluten-induced intestinal damage.

The study enrolled 50 adult participants with coeliac disease who were already following a gluten-free diet with minimal intestinal damage at baseline, as measured by the villous height-to-crypt depth ratio (Vh:Cd ≥2.0). Two weeks after a single subcutaneous dose of TEV-408, participants began a six-week daily gluten challenge. The primary endpoint result showed a least squares mean change from baseline in the Vh:Cd ratio of -0.43 for TEV-408 versus -0.88 for placebo, a treatment difference of 0.45 (95% CI: 0.06 to 0.84; p<0.05). The compound also showed a markedly lower intraepithelial lymphocyte density increase compared with placebo (0.37 versus 27.60) and lower gastrointestinal symptom scores on the Coeliac Disease Symptom Diary, a validated patient-reported outcome measure. TEV-408 was well-tolerated with no safety signals observed to date.

The science and the programme

IL-15 is a cytokine with a well-established role in driving immune-mediated intestinal inflammation in coeliac disease, making it a biologically credible target. By blocking IL-15 activity, TEV-408 is designed to interrupt the downstream cascade that damages the intestinal villi characteristic of the condition. Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva, said the results "underscore the potential to move beyond managing gluten exposure and address coeliac disease at its biological source."

TEV-408 received FDA Fast Track designation for coeliac disease in May 2025. Teva is also evaluating the antibody in a Phase 1b study in vitiligo and has announced plans to advance into a Phase 2b programme in that indication following encouraging early results. This multi-indication strategy is central to Teva's positioning of TEV-408 as a so-called pipeline-in-a-product asset. Royalty Pharma entered a strategic funding agreement with Teva in January 2026 worth up to $500 million to accelerate TEV-408's clinical development, with milestone payments and a royalty on net sales payable to Royalty Pharma upon commercialisation.

Market context and competitive landscape

Coeliac disease is estimated to affect approximately 1% of the global population, with more than three million people affected in the United States alone, many of whom remain undiagnosed. There are currently no approved pharmacological therapies; a strict gluten-free diet remains the only standard of care, and even with rigorous adherence many patients continue to experience symptoms and intestinal damage from inadvertent gluten exposure. That unmet need has attracted a growing number of investigational programmes targeting both the innate and adaptive immune components of the disease pathway.

Several companies have explored gluten-specific enzyme approaches and tight-junction modulators with mixed results, while the field has increasingly turned to immune-pathway biologics. TEV-408 joins a small group of antibody-based candidates in late-phase coeliac studies; the strength of its biopsy-based endpoint data, if confirmed in a larger study, would represent a meaningful differentiation point. Additional analyses from the ongoing Phase 2a study are expected to be presented at a future scientific congress, which will provide clinicians and investors with a fuller picture of the benefit-risk profile before any Phase 3 decision is made.