Teva moves closer to a drug for celiac disease with positive Phase 2 results
The company's TEV-408 antibody met its primary endpoint in a 50-patient trial and reduced intestinal damage, inflammation and gastrointestinal symptoms. Teva is also advancing the treatment for vitiligo, potentially expanding the commercial opportunity for the same drug.
Teva reported positive results from a Phase 2a clinical trial of an experimental treatment for celiac disease, a chronic autoimmune disorder for which there are currently no approved drug treatments.
The trial, which enrolled 50 adults, met its primary endpoint and showed that TEV-408 statistically significantly and clinically meaningfully prevented intestinal damage caused by gluten exposure compared with placebo. The antibody also showed positive effects on reducing intestinal inflammation and improving gastrointestinal symptoms.
The results add to encouraging findings from a separate trial of TEV-408 for vitiligo and strengthen Teva's view that the antibody could potentially become "an entire product portfolio in a single product." According to Teva's estimates, the celiac indication alone could generate annual revenue of $1 billion if the drug is approved.
The results offer hope to the large population living with celiac disease, but even if development proceeds as planned, TEV-408 is not expected to reach the market before 2034.
Celiac disease is a chronic autoimmune disease in which exposure to gluten causes damage to the small intestine. The disease affects about 1% of the world's population and currently has no approved drug treatment. A gluten-free diet is the standard treatment, but many patients continue to experience symptoms, reduced quality of life and ongoing intestinal damage.
“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 Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “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.”
TEV-408 is an experimental antibody developed by Teva to block the activity of IL-15, a protein involved in inflammatory and immune processes. The drug is currently being developed for both celiac disease and vitiligo. In May 2025, the FDA granted TEV-408 Fast Track designation for the treatment of celiac disease, while the vitiligo program was cleared to advance to Phase 2b following encouraging results.
Earlier this year, Teva signed an agreement with Royalty Pharma to accelerate development of TEV-408 for vitiligo, which is at an earlier stage than the celiac program. Under the agreement, Teva could receive up to $500 million for developing the drug, depending on its progress through clinical trial stages.
Sales of TEV-408 for vitiligo are also expected to reach about $1 billion a year if the treatment receives FDA approval. Vitiligo is a chronic autoimmune skin disease that causes patches to appear on the skin as a result of the loss of pigment-producing cells.
An estimated 0.5% to 2% of the world's population suffers from vitiligo, although many cases remain undiagnosed and untreated. Because of the disease's significant visible effects, many patients also experience depression and anxiety. Currently, there is one approved topical treatment for vitiligo, an ointment whose use is limited to 10% of the body's surface. There is no approved drug that targets the underlying cause of the disease rather than only its symptoms.
