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's investigational anti-IL-15 antibody TEV '408 met the primary endpoint in an ongoing Phase 2a study in adults with celiac disease, showing statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo. In the 50-participant randomized study, a single subcutaneous dose produced a least-squares mean Vh:Cd change of -0.43 versus -0.88 for placebo (treatment difference 0.45, 95% CI 0.06-0.84, p<0.05), with lower GI symptom scores and no emerging safety signals.
Key figures
- Drug Name
- TEV '408 (anti-IL-15 monoclonal antibody)
- Phase Of Trial
- Phase 2a in celiac disease; also Phase 1b in vitiligo advancing to Phase 2b
- Ci 95
- (0.06, 0.84)
- P value
- <0.05
- Primary endpoint
- Vh:Cd ratio LS mean change from baseline
- Global prevalence
- approximately 1%
- Us celiac patients
- more than three million
- Treatment difference
- 0.45
- Enrolled participants
- 50
- Iel treatment difference
- -27.23
- Royalty pharma funding up to
- $500 million
- Vh cd ls mean change placebo
- -0.88
- Vh cd ls mean change treatment
- -0.43
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