Teva Pharmaceuticals has announced positive topline results from an ongoing phase 2a study of TEV ‘408, an investigational anti-interleukin-15 monoclonal antibody, in adults with celiac disease. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8. TEV ‘408 was well-tolerated, with no safety signals observed to date.

Eric Hughes, MD, PhD, Executive Vice President (EVP), Global R&D and Chief Medical Officer (CMO), Teva Pharmaceuticals, said, “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. 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.”

The ongoing randomised, placebo-controlled study enrolled 50 adult participants with celiac disease on a Gluten-Free Diet (GFD) with minimal intestinal damage at baseline as measured by the villous height-to-crypt depth ratio and symptoms. Two weeks after receiving a single dose of TEV ‘408, participants began a 6-week daily Gluten Challenge (GC). The study assessed biopsy-based measures of intestinal damage and inflammation along with patient-reported symptoms.

Additional analyses from the ongoing phase 2a study are underway.

The company plans to present further data from the study at a future scientific meeting.