Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product Potential
Teva announced positive topline results from its ongoing Phase 2a study of TEV '408, an investigational anti-IL-15 monoclonal antibody, in adults with celiac disease, with the study meeting its primary endpoint of preventing gluten-induced intestinal damage versus placebo at week 8. In the 50-participant placebo-controlled study, TEV '408 showed a least-squares mean Vh:Cd change of -0.43 versus -0.88 for placebo (treatment difference 0.45, p<0.05), with favorable effects on intestinal inflammation and lower GI symptom scores; the single subcutaneous dose was well-tolerated with no safety signals observed to date.
Key figures
- Drug Name
- TEV '408 (anti-IL-15 monoclonal antibody)
- Phase Of Trial
- Phase 2a
- Primary endpoint
- Vh:Cd ratio LS mean change from baseline of -0.43 for TEV '408 vs -0.88 for placebo
- Enrolled participants
- 50
- Fda fast track designation
- granted May 2025 in celiac disease
- Iel density ls mean change
- increase of 27.60 for placebo vs 0.37 for TEV '408
- Royalty pharma funding cap
- $500 million
- Iel density treatment difference
- -27.23
- Primary endpoint treatment difference
- 0.45, 95% CI: (0.06, 0.84), p<0.05
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