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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 Pharmaceutical Industries Ltd
Wed, September 2, 2026 at 4:33 PM GMT+5:30
7 min read
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Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Antibody
Teva-discovered TEV ‘408, a novel anti-IL-15 monoclonal antibody, demonstrated statistically significant and clinically meaningful prevention of gluten-induced intestinal damage vs placebo following a single subcutaneous dose
TEV ‘408 was well-tolerated with no safety signals observed to date
Together with the vitiligo program, the celiac disease topline results further support TEV ‘408 as a potential pipeline-in-a-product opportunity in multiple diseases
Teva will hold an investor call and live webcast today,Wednesday, September 2, 2026, at 8:00 a.m. ET to discuss these data
TEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from an ongoing Phase 2a study of TEV ‘408, an investigational anti-interleukin-15 monoclonal antibody, in adults with celiac disease. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8. TEV ‘408 was well-tolerated, with no safety signals observed to date.
“A strict gluten-free diet has long been the only option for people living with celiac disease. 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,” saidEric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source. They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage.”
The ongoing randomized, placebo-controlled study enrolled 50 adult participants with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage at baseline as measured by the villous height-to-crypt depth ratio (Vh:Cd ≥2.0) and symptoms. Two weeks after receiving a single dose of TEV ‘408, participants began a six-week daily gluten challenge (GC). The study assessed biopsy-based measures of intestinal damage and inflammation along with patient-reported symptoms. At week 8 (the end of the GC) TEV ‘408:
Showed statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo, as measured by the trial’s primary endpoint of Vh:Cd ratio with a least squares (LS) mean change from baseline of -0.43 compared with -0.88 for placebo (treatment difference of 0.45, 95% CI: (0.06, 0.84), p<0.05)
Showed a favorable effect on intestinal inflammation as measured by density of intraepithelial lymphocytes (IELs) compared with placebo; the LS Mean change from baseline in the density of IELs, was an increase of 27.60 for placebo compared to 0.37 for TEV ‘408 treated participants (treatment difference of -27.23, 95% CI: (-39.67, -14.79))
Demonstrated lower GI symptom scores versus placebo, as assessed using the Celiac Disease Symptom Diary (CDSD), a patient-reported outcome (PRO)
Was well-tolerated with no emerging safety signals
