Teva's TEV '408 Meets Primary Endpoint in Phase 2a Celiac Disease Trial

Teva Pharmaceutical Industries announced positive topline results from a phase 2a trial of TEV '408, an investigational anti-interleukin-15 (IL-15) monoclonal antibody, showing statistically significant and clinically meaningful prevention of gluten-induced intestinal damage compared with placebo in adults with celiac disease, the company announced September 2, 2026.¹ A single subcutaneous dose of TEV '408 was well tolerated, with no safety signals observed to date.¹

"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, global R&D, and chief medical officer at Teva, in a company press release.¹ "Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage, and a significant impact on their daily lives. These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source."

What did the phase 2a trial show?

The ongoing, randomized, placebo-controlled trial (NCT06807463) enrolled 50 adults with celiac disease on a gluten-free diet with minimal baseline intestinal damage, who received a single dose of TEV '408 or placebo followed by a 6-week daily gluten challenge beginning 2 weeks after dosing. At week 8, the primary endpoint of villous height-to-crypt depth ratio showed a least squares mean change from baseline of -0.43 with TEV '408 compared with -0.88 for placebo, a treatment difference of 0.45 (95% confidence interval [CI], 0.06-0.84; p<0.05).¹ TEV '408 also showed a favorable effect on intraepithelial lymphocyte density, a measure of intestinal inflammation, with a least squares mean change of 0.37 compared with an increase of 27.60 for placebo (treatment difference, -27.23; 95% CI, -39.67 to -14.79), along with lower gastrointestinal symptom scores on the Celiac Disease Symptom Diary.¹

Why is a new treatment needed for celiac disease?

Celiac disease affects an estimated 1% of the global population, or more than 3 million people in the United States alone, and currently has no approved therapies, according to the company.¹ A strict gluten-free diet remains the standard of care, but patients often continue to experience symptoms and intestinal damage from inadvertent gluten exposure.¹

IL-15 is overexpressed in the intestinal epithelium and lamina propria of patients with active celiac disease, where it drives the expansion and cytotoxic activity of intraepithelial lymphocytes that damage the gut lining, making it a validated therapeutic target.² TEV '408, discovered by Teva, is designed with high affinity and potency and a prolonged half-life intended to support convenient subcutaneous dosing.¹

How does this fit into Teva's broader TEV '408 program?

TEV '408 is also being developed for vitiligo, for which it is designed for quarterly subcutaneous dosing. In an open-label phase 1b trial (NCT06625177), nearly 75% of patients reported improvement in facial vitiligo at week 24, with about half describing themselves as "much" or "very much" improved, and no safety signals were observed.³ Following those results, Teva is advancing TEV '408 into a phase 2b vitiligo trial planned for the 4th quarter of 2026.³

TEV '408 previously received FDA fast track designation for celiac disease in May 2025, and Teva entered a strategic funding agreement with Royalty Pharma in January 2026 under which it is eligible to receive up to $500 million to accelerate the program's development in exchange for future milestone and royalty payments if TEV '408 is approved and launched.¹

What are the limitations?

These data are topline results from a single-dose, phase 2a study, and additional analyses and longer-term data have not yet been reported or published. Teva said it plans to present further data at a future scientific meeting. The trial enrolled a relatively small population of 50 patients already following a gluten-free diet.

References

1. Teva Pharmaceutical Industries. 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. Press release. Published September 2, 2026. Accessed September 2, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/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/default.aspx
2. Abadie V, Jabri B. IL-15: a central regulator of celiac disease immunopathology. Immunol Rev. 2014;260(1):221-234. doi:10.1111/imr.12191
3. Teva Pharmaceutical Industries. Teva to advance its anti-IL-15 antibody, designed for quarterly dosing, into phase 2b development in vitiligo, following encouraging phase 1b results. Press release. Published July 7, 2026. Accessed September 2, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-to-Advance-Its-Anti-IL-15-Antibody-Designed-for-Quarterly-Dosing-Into-Phase-2b-Development-in-Vitiligo-Following-Encouraging-Phase-1b-Results/default.aspx