Teva Reports Positive Phase 2a Trial Results for Celiac Disease Drug Candidate

Teva Pharmaceuticals announced positive results from a Phase 2a clinical trial for TEV-'408, an investigational antibody designed to treat conditions including celiac disease. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in gluten-induced intestinal damage compared to a placebo.

The study involved 50 adult celiac patients adhering to a gluten-free diet who experienced minimal intestinal damage at the trial's outset. After receiving a single subcutaneous dose of TEV-'408, participants underwent controlled daily gluten exposure for six weeks. Eight weeks later, the treatment group showed less damage to the intestinal lining than the placebo group, indicating a protective effect against gluten-induced harm.

Beyond the primary goal, Teva reported positive impacts on intestinal inflammation markers and lower gastrointestinal symptom scores in the treatment group. The company stated the drug was well-tolerated with no new safety concerns identified. TEV-'408 targets IL-15, a protein involved in inflammatory and immune pathways, aiming to reduce the immune response that damages the intestine after gluten exposure.

In May 2025, TEV-'408 received Fast Track designation from the FDA for celiac disease. Teva is also exploring TEV-'408 for vitiligo, with positive Phase 1b results leading to a Phase 2b trial. This multi-indication potential leads Teva to describe the molecule as a "pipeline-in-a-product."

Financially, Teva partnered with Royalty Pharma in January, potentially receiving up to $500 million to accelerate TEV-'408's clinical development. Celiac disease, an autoimmune disorder affecting about 1% of the global population, currently lacks an approved drug treatment beyond gluten avoidance. Teva plans to present further data at a scientific conference and will hold an investor call to discuss development plans, including future trial sizes and the asset's potential within its innovative drug pipeline.