TEL AVIV, Israel, September 2, 2026
Teva Pharmaceutical Industries Ltd. has reported positive topline results from its ongoing Phase 2a study of TEV ‘408 in adults with celiac disease, with the investigational anti-interleukin-15 (IL-15) monoclonal antibody achieving the study’s primary endpoint. A single subcutaneous dose of TEV ‘408 demonstrated statistically significant and clinically meaningful prevention of gluten-induced intestinal damage compared with placebo at Week 8. The treatment was also well-tolerated, with no emerging safety signals reported to date, providing further clinical support for Teva’s development of TEV ‘408 as a potential therapy for celiac disease and other immune-mediated conditions.
TEV ‘408 Protects Against Intestinal Damage
The randomized, placebo-controlled Phase 2a study enrolled 50 adults with celiac disease who were following a gluten-free diet and had minimal intestinal damage at baseline. Two weeks after receiving a single dose of TEV ‘408, participants underwent a six-week daily gluten challenge designed to assess whether IL-15 inhibition could protect against gluten-triggered intestinal injury. At Week 8, the primary endpoint showed a least-squares mean change in the villous height-to-crypt depth (Vh) ratio of -0.43 with TEV ‘408 compared with -0.88 for placebo, resulting in a treatment difference of 0.45 with a 95% confidence interval of 0.06 to 0.84 and p<0.05. TEV ‘408 also demonstrated a favorable effect on intestinal inflammation, with a substantially smaller increase in intraepithelial lymphocyte (IEL) density compared with placebo, while lower gastrointestinal symptom scores were observed using the Celiac Disease Symptom Diary.
Anti-IL-15 Approach Addresses Disease Biology
TEV ‘408 is a human monoclonal antibody designed to inhibit IL-15, a cytokine involved in immune-mediated pathways associated with celiac disease. By blocking IL-15 activity, Teva aims to reduce the intestinal inflammation and tissue damage triggered by gluten exposure. The candidate has a high in-vitro affinity and potency and a prolonged half-life that supports the potential for subcutaneous dosing. TEV ‘408 received FDA Fast Track designation for celiac disease in May 2025 and is also being evaluated in a Phase 1b study in vitiligo. Following encouraging vitiligo data, Teva is advancing the program toward a Phase 2b study, supporting the company’s view of TEV ‘408 as a potential pipeline-in-a-product opportunity across multiple immune-mediated diseases.
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Teva Advances TEV ‘408 Development
The positive celiac disease results provide an important clinical milestone for Teva as additional analyses from the ongoing Phase 2a study continue. The company plans to present further data at a future scientific meeting. Teva is developing TEV ‘408 in a setting where a strict gluten-free diet remains the standard of care, with patients continuing to face symptoms and intestinal damage despite careful dietary management. The company entered a strategic funding agreement with Royalty Pharma in January 2026 under which Teva is eligible to receive up to $500 million to accelerate development of TEV ‘408. With positive Phase 2a data in celiac disease and ongoing development in vitiligo, TEV ‘408 is emerging as a potentially broad immunology asset centered on IL-15 pathway inhibition.
Source: Teva Pharmaceutical Industries, press relese
