TEV '408
- Indication
- Celiac disease on a gluten-free diet
- Stage
- phase2
- Event
- End of Phase Meeting
- Details
September 2, 2026: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported positive topline results from an ongoing Phase 2a study of TEV-408, an investigational anti-IL-15 monoclonal antibody, in adults with celiac disease. In the randomized, placebo-controlled trial (50 participants on a gluten-free diet), the study met its primary endpoint at week 8, showing statistically significant prevention of gluten-induced intestinal damage versus placebo after a single subcutaneous dose followed by a six-week gluten challenge: LS mean change in villous height-to-crypt depth ratio was -0.43 for TEV-408 vs -0.88 for placebo (treatment difference 0.45; 95% CI 0.06 to 0.84; p<0.05).
TEV-408 also showed a favorable effect on intestinal inflammation, with LS mean change in intraepithelial lymphocyte density of 0.37 vs 27.60 for placebo (treatment difference -27.23; 95% CI -39.67 to -14.79), and lower GI symptom scores on the Celiac Disease Symptom Diary. TEV-408 was well tolerated with no emerging safety signals.
Teva said additional analyses are underway and plans to present further data at a future scientific meeting. The program received FDA Fast Track designation for celiac disease in May 2025.
Separately, TEV-408 is in an ongoing Phase 1b vitiligo study, and Teva is advancing it into Phase 2b in vitiligo.
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