Teva's Experimental Drug Shows Promise in Celiac Disease Clinical Trial
Translated & summarized from Ynet by baba
Teva Pharmaceuticals reported positive interim results from a clinical trial for its experimental antibody, TEV-'408, showing it protected the small intestine from gluten damage in celiac disease patients. The drug, developed in Israel, is well-tolerated and may offer a new treatment beyond a gluten-free diet.
The story in 6 lines · by baba
- Teva's experimental antibody TEV-'408 shows promise in protecting the intestine from gluten damage.
- A Phase 2a trial reported positive interim results for the drug in celiac disease patients.
- The drug targets the IL-15 protein, involved in the immune response causing intestinal damage.
- TEV-'408 is also being investigated for the autoimmune skin condition vitiligo.
- The U.S. FDA granted the drug Fast Track designation for celiac disease.
- Analysts estimate potential annual sales of $1.5 billion for the celiac indication.
Teva Pharmaceuticals has announced positive interim results from a Phase 2a clinical trial for its experimental antibody, TEV-'408, developed at its Netanya laboratories. The drug aims to protect the small intestine from gluten-induced damage in celiac disease patients, a condition currently managed solely by a strict, lifelong gluten-free diet.
The randomized, placebo-controlled trial involved 50 adults with celiac disease whose intestinal lining was nearly normal at the study's start. Participants received a single subcutaneous injection of TEV-'408 and were then exposed to daily gluten for six weeks. The primary endpoint measured the ratio of villus height to crypt depth in the intestinal lining, a standard indicator of damage.
Results showed a statistically significant reduction in damage in the TEV-'408 group compared to the placebo group. Inflammation markers and self-reported gastrointestinal symptoms were also lower in the treatment group. The antibody was well-tolerated, with no safety signals identified to date.
Dr. Eric Hughes, Teva's EVP and Chief Medical Officer, stated that the results highlight the potential to move beyond managing gluten exposure and treat the disease at its biological source by targeting the IL-15 protein. This Israeli-developed antibody is also being tested for the autoimmune skin condition vitiligo, as both diseases share a common immune mechanism involving IL-15.
Teva has secured up to $500 million in funding from Royalty Pharma to accelerate the antibody's development. Analysts estimate the drug's sales potential for celiac disease alone at approximately $1.5 billion annually. The U.S. Food and Drug Administration (FDA) granted TEV-'408 Fast Track designation for celiac disease in May 2025, facilitating a potentially expedited review process.
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