Teva Reports Promising Early Results for Celiac Disease Drug

Teva Pharmaceuticals announced positive preliminary results from a clinical trial for its experimental drug, TEV-408, aimed at treating celiac disease. The Phase 2a trial, involving 50 adults with celiac disease, met its primary endpoint by demonstrating a statistically significant and clinically meaningful reduction in intestinal damage caused by gluten exposure compared to a placebo group. Participants receiving the drug also experienced decreased intestinal inflammation and improved gastrointestinal symptoms after eight weeks of treatment.

Teva reported that TEV-408 was well-tolerated, with no new safety concerns identified. The drug is an experimental antibody designed to block the protein IL-15, which plays a role in inflammatory processes and immune system activity. Teva is also developing TEV-408 for vitiligo, with plans to advance that program to Phase 2b following encouraging outcomes.

This development could be particularly significant for celiac disease patients, a chronic autoimmune condition affecting about 1% of the global population. Currently, the only treatment is a strict gluten-free diet, which doesn't fully alleviate symptoms or prevent intestinal damage for all individuals. Teva views these trial results as a crucial step toward a drug that addresses the disease's biological mechanisms.

Dr. Eric Hughes, Teva's Senior Vice President and Head of Global R&D and Chief Medical Officer, stated that the results highlight the potential to move beyond managing gluten exposure and treat the disease at its biological source. He noted that even with strict diets, many celiac patients continue to suffer from symptoms and daily life impacts.

Earlier, in May 2025, the U.S. Food and Drug Administration (FDA) granted TEV-408 Fast Track designation for celiac disease treatment. Teva believes the positive results in both celiac disease and vitiligo underscore the drug's potential for multiple inflammatory and immune-mediated conditions.