Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) on Wednesday reported positive top-line results from an ongoing Phase 2a study of TEV '408, an investigational anti-interleukin-15 monoclonal antibody for adults with celiac disease.
The trial met its primary endpoint, showing statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8, with no safety signals observed.
The randomised, placebo-controlled study enrolled 50 adults on a gluten-free diet with minimal baseline intestinal damage. Two weeks after a single subcutaneous dose of TEV '408, participants began a six-week daily gluten challenge, with intestinal damage, inflammation and symptoms assessed throughout.
At week 8, TEV '408 produced a least squares mean change in villous height-to-crypt depth ratio of -0.43 versus -0.88 for placebo, a treatment difference of 0.45 (95% CI: 0.06, 0.84; p
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