Teva Drug Shows Promise for Celiac Disease in Clinical Trials

Teva Pharmaceuticals has announced promising results from a Phase 2a clinical trial for its experimental drug, TEV-408, in treating celiac disease. The trial, involving 50 adults, met its primary endpoint by demonstrating that the antibody successfully prevented intestinal damage following gluten exposure compared to a placebo. The drug also showed a statistically significant and clinically meaningful reduction in intestinal inflammation and improvement in digestive symptoms.

These findings for celiac disease complement earlier encouraging results from trials of TEV-408 for vitiligo, an autoimmune skin condition. Teva believes the antibody has the potential to become a versatile treatment for multiple autoimmune disorders. The company estimates that the celiac indication alone could generate annual revenues of $1 billion.

Celiac disease is a chronic autoimmune disorder affecting about 1% of the global population, where gluten consumption damages the small intestine. While a gluten-free diet is the standard treatment, many patients continue to experience symptoms and ongoing intestinal damage. Dr. Eric Hughes, Teva's Senior Vice President and Head of Global R&D and Chief Medical Officer, stated that these results highlight the potential to move beyond managing gluten exposure and treat the disease at its biological root.

TEV-408, developed by Teva, is an investigational antibody designed to block the activity of IL-15, a protein involved in inflammatory and immune processes. The U.S. Food and Drug Administration (FDA) granted TEV-408 Fast Track designation for celiac disease in May 2025. The vitiligo development program is advancing to Phase 2b following positive interim results.

Earlier this year, Teva secured an agreement with Royalty Pharma to accelerate the development of the antibody for vitiligo, potentially receiving up to $500 million based on clinical trial progress. Sales for the vitiligo treatment are also projected to reach approximately $1 billion annually if approved by the FDA. Vitiligo affects an estimated 0.5% to 2% of the world's population, causing pigment cell loss and skin discoloration. Current treatments are limited, with only one topical option available for a small percentage of body surface area, and it does not address the underlying causes of the disease.