Teva TEV-408 Phase 2a Results
Teva TEV-408 Phase 2a results show significant prevention of gluten-induced intestinal damage; FDA Fast Track and investor call create near-term catalysts.
KEY TAKEAWAYS
- Phase 2a topline met the primary endpoint, preventing gluten-induced intestinal damage versus placebo.
- Marked IEL reduction and lower GI symptom scores supported anti-IL-15 activity and tolerability.
- FDA Fast Track and investor conference call create near-term catalysts and prompt further analyses.
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Teva Pharmaceutical Industries Ltd. said on Sept. 2, 2026, that TEV‑408 met its primary endpoint in a randomized, placebo-controlled Phase 2a celiac gluten-challenge study. The investigational anti-interleukin-15 (IL-15) antibody showed significant prevention of gluten-induced intestinal damage, prompting further analyses and an investor call.
Phase 2a Efficacy Results
Teva reported that the trial met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage at week 8. The least-squares mean change from baseline in villous height-to-crypt depth (Vh:Cd) ratio was −0.43 for TEV‑408 and −0.88 for placebo, a treatment difference of 0.45 (95% confidence interval 0.06 to 0.84; p < 0.05).
TEV‑408 also showed a favorable effect on intestinal inflammation measured by intraepithelial lymphocyte (IEL) density. The placebo group had a least-squares mean increase of 27.60 compared with 0.37 for TEV‑408, yielding a treatment difference of −27.23 (95% CI −39.67 to −14.79).
On patient-reported outcomes, TEV‑408 demonstrated lower gastrointestinal symptom scores versus placebo on the Celiac Disease Symptom Diary (CDSD). The company said TEV‑408 was well-tolerated with no emerging safety signals identified in the topline disclosure.
Study Design and Outlook
The Phase 2a study enrolled 50 adults with celiac disease on a gluten-free diet who had minimal baseline intestinal damage (Vh:Cd ≥ 2.0) and symptoms. Participants received a single subcutaneous injection of TEV‑408 or placebo, followed two weeks later by daily gluten consumption for six weeks, constituting an eight-week gluten-challenge period. The study is ongoing.
TEV‑408 holds U.S. Food and Drug Administration Fast Track designation for celiac disease, granted in May 2025. Teva’s investor-relations events page lists an "IL-15 Celiac Disease Phase 2a Topline Results – Conference Call," indicating a near-term briefing on the data. The company describes TEV‑408 as an internally discovered anti-IL-15 antibody that blocks interleukin-15, a cytokine involved in the immune response to gluten. The program is also in a Phase 2b study for vitiligo.
Additional analyses from the ongoing study are underway, with further data planned for presentation at a future scientific meeting. The Fast Track status and scheduled investor event create near-term catalysts for the IL-15 program, which Teva frames as strategically important.
