Teva reports positive Phase IIa results for celiac disease drug TEV-408

Teva Pharmaceutical Industries has reported positive topline results from a Phase IIa clinical trial for TEV-408, an experimental anti-IL-15 antibody candidate designed to treat celiac disease. The study met its primary endpoint, demonstrating statistically significant effects on intestinal damage during a six-week gluten challenge.

The randomized trial involved 50 adults with celiac disease. Participants received a single dose of TEV-408 followed by a daily intake of 3 grams of gluten for six weeks. Results showed that TEV-408 significantly mitigated intestinal injury, measured by the ratio of villous height to crypt depth, compared to the placebo group. The drug also showed favorable effects on intraepithelial lymphocytes, which are immune cells associated with intestinal inflammation.

TEV-408 was well tolerated with no new safety signals identified. While currently being tested for celiac disease, the drug is also being evaluated for vitiligo. If successful in future development, TEV-408 could provide a pharmacological treatment option for celiac disease, which currently relies primarily on strict gluten avoidance.