Teva Pharmaceutical 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 eight. TEV ‘408 was well-tolerated, with no safety signals observed to date.
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 (Vh:Cd ≥2.0) and symptoms. Two weeks after receiving a single dose of TEV ‘408, participants began a six-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. Teva plans to present further data from the study at a future scientific meeting.
