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Teva’s Investigational Celiac Disease Drug Shows Positive Phase 2a Results

Teva Pharmaceuticals reports positive Phase 2a results for TEV'408, an investigational anti-IL-15 antibody for celiac disease, as covered by Celiac Disease Foundation.

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An investigational drug for celiac disease has just posted its first clinical results, and the celiac community’s own advocacy organizations are taking notice. According to Celiac Disease Foundation, which covered the announcement on its website, pharmaceutical company Teva Pharmaceuticals reported positive topline results from a Phase 2a study of TEV’408, an investigational human monoclonal antibody that blocks interleukin-15 (IL-15), a cytokine involved in the immune response that drives intestinal damage in celiac disease.

The results, announced by Teva on September 2, 2026, come from a randomized, placebo-controlled Phase 2a trial enrolling 50 adults with celiac disease who were following a gluten-free diet and had minimal intestinal damage at baseline. Participants received a single subcutaneous dose of TEV’408 or placebo, followed two weeks later by a six-week daily gluten challenge designed to provoke measurable intestinal injury under controlled conditions.

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Photo by Ksenia Yakovleva on Unsplash

On the trial’s primary endpoint, the villous height-to-crypt depth ratio (Vh:Cd) at week 8 — a standard histological measure of intestinal damage in celiac disease — participants on TEV’408 showed a mean change of -0.43, compared with -0.88 for placebo, a statistically significant treatment difference of 0.45 (p<0.05). In practical terms, that means the drug substantially limited the intestinal damage normally triggered by gluten exposure. On a key secondary endpoint, intraepithelial lymphocyte density — another marker of immune activity in the gut lining — the treatment group saw a much smaller increase (+0.37) than placebo (+27.60). Participants on TEV’408 also reported comparatively lower gastrointestinal symptoms on the Celiac Disease Symptom Diary during the gluten challenge.

Teva reported that the drug was well tolerated in the study, with no new safety signals identified. “A strict gluten-free diet has long been the only option for people living with celiac disease, yet many continue to experience symptoms and intestinal damage despite their best efforts,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, in the company’s announcement. Teva said further analyses of the trial data are underway and will be presented at a future scientific meeting, and that the IL-15 program is also advancing into a separate Phase 2b study in vitiligo.

It’s worth being clear about what this milestone does and doesn’t mean. A positive Phase 2a result is an early, encouraging signal — not a finished, approved treatment. The gluten-free diet remains the only medically recommended management for celiac disease today, and no drug has yet completed the additional, larger trials that regulators require before approval. Still, for a community that has waited decades for pharmaceutical options beyond strict dietary avoidance, a mechanistically distinct approach that measurably blunted gluten-triggered gut damage in a controlled study is meaningful progress worth tracking.

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Celiac Disease Foundation’s coverage of the announcement reflects the broader interest patient organizations are taking in this pipeline, as part of their ongoing work following celiac disease drug development on behalf of the community. Anyone following celiac research closely can expect more detail as Teva presents fuller data from this study at an upcoming scientific meeting.

For another recent piece of research, read our report on the study that found a celiac immune reaction at just 3 mg of gluten. And while legitimate drug trials like this one move forward, it’s worth debunking a persistent myth: homeopathy cannot cure celiac disease.

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Manu
Manu

¡Hola! Soy Manu, ingeniero químico, profesor de biología y cofundador de Glutendtrotters. Me encargo de la parte técnica del sitio y comparto consejos en las secciones de tips de viaje y celiaquía. Con tiroiditis de Hashimoto, sé lo que implica vivir sin gluten. Mi curiosidad, junto con mi pasión por la ciencia, me llevan a explorar el mundo y disfrutar de una buena comilona sin gluten.

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