Teva’s TEV-408 Meets Primary Endpoint in Phase 2a Celiac Study

Teva Pharmaceutical's investigational anti-IL-15 monoclonal antibody TEV '408 has cleared a meaningful clinical threshold in celiac disease, a condition with no approved pharmacological treatment, a result that opens a defined regulatory pathway and raises immediate questions about subcutaneous formulation scale-up and biologics manufacturing readiness.

The ongoing randomized, placebo-controlled Phase 2a study enrolled 50 adults with celiac disease on a gluten-free diet. Two weeks after a single subcutaneous dose of TEV '408, participants underwent a six-week daily gluten challenge. At week 8, the study met its primary endpoint: villous height-to-crypt depth ratio (Vh:Cd) showed a least squares mean change from baseline of -0.43 for TEV '408 versus -0.88 for placebo (treatment difference 0.45; 95% CI: 0.06, 0.84; p<0.05). Intraepithelial lymphocyte density increased by 27.60 in the placebo arm compared to 0.37 in the treated group, and patient-reported GI symptom scores via the Celiac Disease Symptom Diary also favored TEV '408.

For biologics manufacturing and QA teams, the single-dose subcutaneous design is operationally significant. TEV '408 carries a prolonged half-life engineered to support infrequent dosing intervals, a formulation characteristic that will shape fill-finish requirements, cold-chain specifications, and container-closure integrity validation as the program advances toward Phase 3. No safety signals have been observed to date, which preserves the program's forward momentum without the burden of a revised risk management framework at this stage.

The celiac result compounds data from Teva's parallel vitiligo program using the same molecule, reinforcing the company's characterization of TEV '408 as a pipeline-in-a-product asset across IL-15-mediated indications. For regulatory affairs leads, celiac disease's status as an indication with no approved pharmacological therapy may support an expedited designation discussion with FDA under existing guidance for unmet medical need, though Teva has not publicly confirmed that pursuit. Additional analyses from the Phase 2a study remain underway, with further data expected at a future scientific meeting.

The next measurable checkpoint is Teva's planned scientific presentation, where biopsy-based histology and full safety data will determine whether the Phase 2a package is sufficient to anchor a Phase 3 protocol and initiate the process validation planning that large-scale monoclonal antibody manufacturing demands.

Source: Teva Pharmaceutical Industries Ltd. via GlobeNewswire, September 2, 2026. Investor call and live webcast held September 2, 2026, at 8:00 a.m. ET / 2:00 p.m. CET.