An experimental Teva Pharmaceutical Industries drug prevented intestinal damage in patients with celiac disease, meeting the main goal of a mid-stage clinical trial in this prevalent autoimmune disease of the gut that currently has no FDA-approved therapies.
In addition to the intestinal improvement as assessed by biopsy, the preliminary Phase 2a results reported Wednesday for the drug, TEV-53408 (TEV ’408 for short), show lower gastrointestinal symptom scores compared to a placebo. So far, the study drug has been safe and well tolerated. Teva said more data would be presented at future scientific meeting.
Celiac disease develops as an immune response to gluten in food. An estimated 5.1 million people in the U.S. and the five largest countries in the European Union have this condition. While celiac disease is typically managed by avoiding gluten-containing foods, half of patients still experience persistent symptoms, Teva said in an investor presentation. The chronic condition damages villi, tiny projections that line the small intestines and absorb nutrients from food.
TEV ’408 is a monoclonal antibody designed to block interleukin-15 (IL-15), a signaling protein involved in immune-mediated pathways, including the inflammation and intestinal damage that develops from celiac disease. This drug, discovered in Teva’s labs, was developed for subcutaneous dosing. It also has a long-half life that could extend the dosing interval to potentially every three months.
The placebo-controlled Phase 2a study enrolled 50 adults with celiac disease who were on a gluten-free diet. These participants had minimal intestinal damage at baseline. Two weeks after receiving a single dose of the study drug, patients began a six-week daily gluten challenge — eating food with gluten to see if it leads to an immune response indicative of celiac disease. The state of patient intestines was assessed with biopsy measures along with patient-reported symptoms.
At the end of week 8, Teva said results showed statistically significant and clinically meaningful prevention of gluten-induced intestinal damage compared to a placebo. Patients in the study will continue to be followed through week 80 to assess the durability and safety of the experimental Teva therapy.
“These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source,” Teva Chief Medical Officer Eric Hughes said in a prepared statement. “They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage.”
The results in celiac disease come about two months after Teva reported results from a Phase 1b test of TEV ’408 in vitiligo, a disorder in which the immune system attacks pigment-producing cells in the skin, leading to discoloration. The drug is proceeding to a Phase 2b test in this indication. Teva said Wednesday that the results in celiac disease further validate the drug’s potential to address many different immunological indications. For celiac disease alone, the company projects TEV ’408 reaching $1.5 billion to $2 billion in peak sales, according to the presentation. Other potential indications include eosinophilic esophagitis, alopecia areata, and atopic dermatitis.
Teva’s drug faces potential competition. Forte Biosciences’ lead asset is an antibody designed to block CD122, a subunit of the IL-2 and IL-15 receptors. Argenx acquired Forte for $2.2 billion, a deal that followed the biotech’s announcement of encouraging early clinical data for its antibody in celiac disease and vitiligo.
First Track Biotherapeutics is developing its own CD122-targeting antibody, ANB033, for celiac disease and eosinophilic esophagitis. Leerink Partners analyst David Risinger, who follows First Tracks, said in a research note that ANB033’s broader mechanism addressing both IL-2 and IL-15 should enable a more comprehensive approach compared to Teva’s blocking of IL-15 alone. But that still needs to be demonstrated with clinical data. In its report of second quarter 2026 financial results, First Tracks said the celiac study has completed enrollment for the gluten challenge cohort; preliminary data from this Phase 1b test are expected in the fourth quarter of this year.
As for Teva, the company said it will proceed to a multiple-dose Phase 2 study to define the dose and regimen for a Phase 3 test of TEV ’408 in celiac disease. Clinical development of the drug is supported by an agreement with Royalty Pharma early this year. The pact provides Teva with up to $500 million. If an approved TEV ’408 reaches the market, Teva will owe Royalty Pharma a milestone payment as well as a royalty on global sales of the product.
Photo: Menahem Kahana, Getty Images
