Teva TEV-408 Anti-IL-15 Monoclonal Antibody Hits Primary Endpoint in Phase 2a Celiac Disease Study; 27-Point IEL Density Advantage Over Placebo at Week 8
Teva Pharmaceutical Industries (NYSE: TEVA) announced Wednesday September 2, 2026 positive topline results from the ongoing Phase 2a study of TEV-408 (an investigational anti-interleukin-15 monoclonal antibody) in adults with celiac disease already following a gluten-free diet. The 50-patient study met its primary endpoint by demonstrating statistically significant and clinically substantive prevention of gluten-induced intestinal damage versus placebo at Week 8. Key efficacy: LS mean change from baseline in intraepithelial lymphocyte (IEL) density was +27.60 for placebo versus +0.37 for TEV-408 (treatment difference -27.23, 95% CI: -39.67 to -14.79). TEV-408 also demonstrated lower gastrointestinal symptom scores versus placebo on the patient-reported Celiac Disease Symptom Diary. Safety was clean with no signals observed. TEV-408 received FDA Fast Track designation in May 2025 and represents a novel mechanism in celiac disease where no disease-modifying therapies are approved and standard-of-care remains strict gluten-free diet adherence. Teva positioned the win as further validation of its 'pipeline-in-a-product' anti-IL-15 platform strategy.