Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) 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, showing statistically significant prevention of gluten-induced intestinal damage compared to placebo at week 8. The trial enrolled 50 adult participants already following a gluten-free diet with minimal intestinal damage at baseline. Participants received a single subcutaneous dose of TEV '408 two weeks before beginning a six-week daily gluten challenge.

The primary endpoint, measured by the villous height-to-crypt depth ratio, showed a least squares mean change from baseline of -0.43 for TEV '408 versus -0.88 for placebo, a treatment difference of 0.45 (95% CI: 0.06, 0.84; p<0.05).

TEV '408 also showed a favorable effect on intestinal inflammation as measured by intraepithelial lymphocyte density. The least squares mean change from baseline was an increase of 27.60 for placebo compared to 0.37 for TEV '408 participants. Lower gastrointestinal symptom scores versus placebo were also reported using the Celiac Disease Symptom Diary. The drug was described as well-tolerated with no safety signals observed to date.

"A strict gluten-free diet has long been the only option for people living with celiac disease," said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source."

Teva said additional analyses from the Phase 2a study are ongoing and that further data will be presented at a future scientific meeting. The company also noted TEV '408 is being studied in vitiligo, describing it as a potential treatment candidate across multiple diseases.