Teva's vitiligo drug shows promising results for celiac disease treatment

Teva reported positive results in a clinical trial for the treatment of celiac disease, a chronic autoimmune condition for which there is currently no approved drug treatment. The trial met its primary endpoint and showed that the treatment succeeded in preventing intestinal damage following gluten exposure compared to a placebo.

The trial, conducted among 50 adults, tested the antibody TEV-408 in phase 2a. It demonstrated a statistically significant and clinically meaningful prevention of intestinal damage, as well as a positive impact on reducing intestinal inflammation and improving gastrointestinal symptoms. These results for TEV-408 join encouraging findings in a trial for the treatment of vitiligo and strengthen the potential of the antibody to become a "whole product portfolio in one product."

According to Teva's estimates, the celiac indication alone could generate annual revenues of 1 billion dollars. However, even if everything proceeds as planned, the drug is not expected to reach the market before 2034.

Celiac disease affects about 1% of the world's population. Although a gluten-free diet is the accepted treatment, many patients continue to experience symptoms and ongoing intestinal damage.

"Until today, a gluten-free diet was the only option, but even patients who strictly adhered to it sometimes continued to suffer. These results highlight the potential to move beyond dealing with gluten exposure and treat the disease at its biological source," said Dr. Eric Hughes, Senior Vice President and Chief Medical Officer at Teva.

TEV-408 is an experimental antibody designed to block the activity of IL-15, a protein involved in inflammatory and immune processes. In May 2025, the FDA granted a fast-track designation to TEV-408 for celiac disease, and the vitiligo development program was cleared to advance to phase 2b.

Earlier this year, Teva signed an agreement with Royalty Pharma to accelerate the development of the antibody for vitiligo. Under the agreement, Teva could receive up to half a billion dollars for development. Sales of the vitiligo treatment are also expected to reach about 1 billion dollars per year if FDA approval is obtained.

Vitiligo is a chronic autoimmune skin disease affecting between 0.5% and 2% of the world's population. Currently, there is only one topical treatment permitted for limited use, with no drug available that treats the underlying causes of the disease rather than just its symptoms.