On October 12th, 2026, First Tracks Biotherapeutics announced positive top-line results from Cohort 1 (gluten-challenge) of ANB033’s Phase 1b trial in celiac disease. ANB033 is an investigational injection given under the skin that targets a protein called CD122, designed to inhibit the signaling of both interleukin-15 (IL-15) and interleukin-2 (IL-2) on immune cells.
IL-15 acts like an alarm signal that helps activate immune cells when a person with celiac disease consumes gluten, and IL-2 is closely linked to symptom development. ANB033 is designed to target CD122 and block IL‑15 and IL‑2 from signaling harmful immune cells that are responsible for intestinal damage in celiac disease. In simpler terms, ANB033 aims to interrupt the immune system’s reaction to gluten before it can cause inflammation and damage to the small intestine. Rather than breaking down gluten or preventing it from entering the body, the drug works by blocking specific signals that tell the immune system to attack.
In the randomized, placebo-controlled Phase 1b trial, ANB033 was administered across two cohorts. Cohort 1 was a 6-week study assessing prevention of gluten-induced intestinal damage and symptoms after a 14-day gluten challenge. Cohort 2 assessed healing of the small intestine in patients with a broad range of intestinal damage and symptom severity across 12 weeks (without a gluten challenge).
Using the Celiac Disease Symptom Diary (CDSD) to assess symptoms, findings indicated that:
- ANB033 prevented an increase in symptoms throughout the entire gluten challenge.
- Only 6% of ANB033 patients took permitted medications to mitigate their digestive symptoms compared to 47% of placebo patients.
- Patients receiving ANB033 reported fewer symptoms overall compared with those receiving a placebo.
“What is especially meaningful about these data is that we saw encouraging signs of protection against damage inside the small intestine and in the symptoms people felt during the gluten challenge, with participants who received ANB033 experiencing no increase in gluten-related symptoms as early as the first day,” said Paul Lizzul, Chief Medical Officer, First Tracks Biotherapeutics. “For people living with celiac disease, these findings suggest that ANB033 may one day offer an additional layer of protection against both intestinal damage and symptoms from accidental gluten exposure. While these are early results and more research is needed, they give us confidence to continue advancing ANB033 for the celiac community, with plans to initiate a late-stage study in 2027.”
The Celiac Disease Foundation played an important role in helping recruit participants for this study, connecting people in the celiac disease community with an opportunity to contribute to research that could advance new treatment options. Celiac Disease Foundation CEO Marilyn Geller also serves on the ANB033 CeD Steering Committee, helping bring the patient perspective to the development of this potential treatment.
These results are an important step forward, but ANB033 is still investigational and is not an approved treatment for celiac disease. More research is needed to understand its safety and effectiveness. The Foundation will continue to follow developments in ANB033 and other potential celiac disease treatments and share updates with the community as more data become available.