Teva’s investigational anti-interleukin-15 monoclonal antibody (mAb) has met its primary endpoint in a Phase IIa trial in celiac disease.
In the study, TEV ‘408 met its primary endpoint of villus height to crypt depth ratio (Vh:Cd) change, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage compared to placebo after eight weeks. TEV ’408 reduced the decline in the Vh:Cd ratio by 0.45 points versus placebo, indicating less gluten-induced intestinal damage. Vh:Cd is a microscopic measurement used to evaluate the health of the small intestine, especially in celiac disease.
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Jeffries analysts touted that TEV ‘408’s Vh:Cd benefit was better than expected, with analysts estimating that the drug is likely to become a blockbuster for Teva. Meanwhile, Leerink analysts agreed that the data was well above the KOL-defined clinically meaningful floor.
The treatment cohort also showed a favourable effect on intestinal inflammation as measured by density of intraepithelial lymphocytes (IELs), with an increase of 27.60 for placebo compared to 0.37 for TEV ‘408 treated patients.
GI symptom scores were also lower in the treatment arm, as assessed using the Celiac Disease Symptom Diary (CDSD), a patient-reported outcome (PRO).
TEV ‘408 was well-tolerated, with no safety signals observed to date.
Dr Eric Hughes, executive VP of global R&D and CMO at Teva, said: “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. 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 randomised, placebo-controlled study enrolled 50 adult participants with celiac disease on a gluten-free diet (GFD). Two weeks after receiving a single dose of TEV ‘408, patients began a six-week daily gluten challenge (GC).
Additional analyses from the ongoing Phase IIa study are underway, with Teva planning to present further data from the study at a future scientific meeting.
Currently, the standard of care for celiac disease is a strict, lifelong gluten-free diet combined with diagnostic confirmation, specialised dietitian support, and regular annual health monitoring. Therefore, pharmaceutical interventions would be beneficial for both patients and caregivers.
While there are no US Food and Drug Administration (FDA)-approved drugs for celiac disease, the clinical pipeline is growing.
Beyond Teva’s efforts, Sanofi is investigating amlitelimab, an OX40L inhibitor monoclonal antibody (mAb) in a Phase II trial (NCT06557772), while Chugai Pharmaceutical is investigating DONQ52 in a Phase II study (NCT07239336).
Teva is also evaluating TEV ‘408 in vitiligo, with a Phase IIb trial planned to start later this year. In January 2026, Royalty Pharma pledged $500m to support the drug’s development in the skin condition in exchange for future royalties and a milestone payment.
