For millions worldwide living with celiac disease, mealtime requires constant vigilance against even small amounts of gluten. While strict adherence to a gluten-free diet remains the only established treatment, it may not completely protect patients from inadvertent exposure, persistent symptoms, and intestinal damage. Now, promising clinical trial results from Teva Pharmaceutical Industries offer hope for a potential new therapeutic option. In a Phase 2a study evaluating its investigational monoclonal antibody TEV ’408, researchers found that a single injection significantly protected patients’ intestines during six weeks of daily gluten exposure.
The study was designed to put the drug to a rigorous test. Fifty adults with celiac disease who had been following a gluten-free diet and had minimal intestinal damage at baseline received a single subcutaneous dose of TEV ’408 or placebo. Two weeks later, participants began a deliberate six-week daily “gluten challenge.” Rather than relying solely on symptoms, investigators performed duodenal biopsies to directly assess changes in the intestinal lining and inflammation.
The trial met its primary endpoint, demonstrating statistically significant protection against gluten-induced intestinal damage at week eight. Researchers evaluated the villous height-to-crypt depth (Vh) ratio, an important measure of intestinal architecture used in assessing celiac disease. Patients receiving placebo experienced a least-squares mean decline of -0.88, while those receiving TEV ’408 saw a decline of -0.43, a statistically significant treatment difference of 0.45. In practical terms, the deterioration in this measure of intestinal damage was roughly half that observed with placebo.
The biological protection extended to intestinal inflammation and symptoms. Intraepithelial lymphocytes (IELs)—immune cells that accumulate in the intestinal lining during the inflammatory response to gluten—increased by 27.60 in the placebo group compared with just 0.37 among participants receiving TEV ’408. Patients treated with the antibody also reported lower gastrointestinal symptom scores on the Celiac Disease Symptom Diary (CDSD). The treatment was well tolerated through the week-eight analysis, with no emerging safety signals reported to date.
TEV ’408 works by selectively binding to and inhibiting interleukin-15 (IL-15), a cytokine that plays an important role in the immune response associated with celiac disease. Dr Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva, emphasized the potential shift in treatment this approach could represent. “A strict gluten-free diet has long been the only option for people living with celiac disease. Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage and a significant impact on their daily lives,” said Hughes. He added, “These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source. They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage.”
Teva describes TEV ’408 as a potential “pipeline-in-a-product” because IL-15 is implicated in multiple immune-mediated diseases. The company is also advancing the antibody into Phase 2b development for vitiligo. That effort is supported by a January 2026 agreement with Royalty Pharma providing $75 million toward Phase 2b development, along with an option for up to an additional $425 million. TEV ’408 has also received US Food and Drug Administration Fast Track designation for the treatment of celiac disease.
While the findings are encouraging, TEV ’408 is not a cure, and the findings do not mean people with celiac disease can abandon a gluten-free diet. The study involved only 50 participants, evaluated a single dose, and the topline results announced so far cover the first eight weeks of an ongoing trial expected to follow participants substantially longer. Still, significantly reducing gluten-induced intestinal damage and inflammation during sustained gluten exposure raises the possibility that TEV ’408 could eventually provide an added layer of protection against inadvertent gluten exposure. Additional analyses are underway, with Teva planning to present further results at upcoming scientific meetings.
