Teva Pharmaceuticals Announces Positive Early Results for Celiac Disease Drug

Teva Pharmaceuticals announced on Wednesday positive preliminary results from its ongoing Phase 2a clinical trial for the experimental drug TEV-408, a novel antibody targeting IL-15 for the treatment of adult celiac disease. The company reported that the trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful prevention of gluten-induced intestinal damage compared to a placebo after eight weeks of treatment. The drug was found to be well-tolerated, with no safety concerns identified to date.

The study involved 50 adults with celiac disease. Teva stated that TEV-408 significantly prevented intestinal damage following gluten exposure and also showed a positive effect in reducing intestinal inflammation and improving digestive symptoms compared to placebo. The company believes these results underscore TEV-408's potential as a "complete product in one product" capable of treating multiple diseases with a shared inflammatory-immune mechanism.

Dr. Eric Hughes, Senior Vice President and Head of Global Research and Development and Chief Medical Officer at Teva, commented that while a gluten-free diet is the only option for celiac patients, many continue to suffer from symptoms, intestinal damage, and significant daily life impacts. He added that these results strengthen Teva's confidence in targeting the IL-15 pathway as an approach to reduce immune-mediated intestinal damage.

TEV-408 is an investigational antibody developed by Teva designed to block the activity of IL-15, a protein involved in inflammatory and immune pathways. The drug is currently under development for celiac disease and vitiligo. In May 2025, the U.S. Food and Drug Administration (FDA) granted it Fast Track designation for the treatment of celiac disease. Teva indicated that its development program for vitiligo is expected to advance to Phase 2b based on the results obtained so far.