By Bailey Arman, associate director of communications, science & education
First Tracks Biotherapeutics has announced positive results from their early-stage clinical trial testing ANB033 for use in celiac disease.
The news marks the third celiac disease clinical trial reporting positive results over the last month or so, alongside Teva and argenx, reigniting the race to be the first company with an approved treatment for celiac disease.
The Study and Initial Results
The results are from a phase 1b study (still technically an early stage out of the three phases of clinical trials) of ANB033, a drug designed to disrupt the immune system’s reaction to gluten in people with celiac disease. Approximately half of the 32 study participants received doses of ANB033, and the others received a placebo—something that looks like the drug, but doesn’t contain any medication. Then, all participants underwent a gluten challenge, eating the same amount of gluten found in two slices of bread each day for 14 days.
Participants who received the placebo had an increase in symptoms, intestinal damage, and immune markers of active celiac disease, whereas participants who received the drug had no increase in symptoms, a decrease in immune markers, and less intestinal damage. Altogether, this initial data suggests ANB033 can help reduce symptoms and prevent intestinal damage caused by gluten consumption.
In addition to these promising results, none of the participants who received the drug reported serious side effects or dropped out of the trial.
Next Steps
This study actually has two parts—these results are from the first part, which followed a cohort of participants on a 6-week timeline, and we expect results from the second, which follows participants on a 12-week timeline, in the first quarter of 2027.
The First Tracks team will share more details from the first cohort’s results at the International Celiac Disease Symposium in November of 2026 (an event that Beyond Celiac has proudly sponsored and will attend—tickets are available for professionals and patients).
As for long-term goals, First Tracks has already confirmed they plan to move the drug forward to another trial, likely starting in 2027. Because the US Food and Drug Administration (FDA) has designated ANB033 for the Fast Track program, the FDA may review their work more quickly, so that people with celiac disease can get a safe and functional treatment sooner rather than later. First Tracks is also studying whether ANB033 can be used for other autoimmune diseases, including eosinophilic esophagitis and vitiligo.
If you want to get involved with research in the meantime, consider:
- Participating in an open clinical trial.
- Reading more celiac disease research by visiting our research newsfeed or subscribing to our research newsletter.
- Following us on social media (@beyondceliac on all major platforms) or subscribing to our email, so that you hear when more trials open.
Finally, we acknowledge and profusely thank the volunteers who participated in this trial for their contributions. Future treatments for celiac are not possible without their generous involvement.