Teva Reports Positive Phase 2a Trial Results for Celiac Disease Drug

Teva Pharmaceuticals announced positive preliminary results from a Phase 2a clinical trial for its antibody, TEV '408, as a treatment for celiac disease. The antibody, which targets IL-15, also showed encouraging findings in trials for the skin condition vitiligo. The trial in adults with celiac disease met its primary endpoint, demonstrating a statistically significant and clinically meaningful prevention of gut damage caused by gluten exposure compared to a placebo, after eight weeks of treatment. TEV '408 was well-tolerated, with no safety concerns identified to date.

Teva views TEV '408 as a potential "pipeline-in-a-product," capable of treating multiple diseases with a shared inflammatory-immune mechanism. Dr. Eric Hughes, Senior Vice President and Head of Global R&D and Chief Medical Officer at Teva, stated that the results highlight the potential to move beyond managing gluten exposure and treat the disease at its biological source. He added that the findings reinforce Teva's focus on the IL-15 pathway to reduce immune-mediated gut damage.

Currently, a gluten-free diet is the only option for individuals with celiac disease, but many continue to experience symptoms and gut damage. Teva estimates the sales potential for the celiac disease indication alone to be between $1.5 billion and $2 billion if the drug reaches the market. Teva, led by CEO Richard Francis, is listed on the New York and Tel Aviv stock exchanges and has seen a 16% increase in its stock price year-to-date. The company's stock reacted positively to the news in pre-market trading and on the local exchange.