New drug may offer treatment for coeliac disease

First Tracks Biotherapeutics’ experimental treatment for coeliac disease, ANB033, reduced symptoms and helped prevent gut damage after gluten exposure in an early-stage trial, the company said today.

Trial shows gut protection

The 32-patient trial found that ANB033 significantly reduced gluten-related gut damage compared with a placebo.

All patients had been diagnosed with coeliac disease at least a year before the trial. Despite sticking to a gluten-free diet, they still had moderate damage to their gut.

Just 6% of patients given ANB033 needed medication to ease gut symptoms, against 47% of those who received a placebo.

Patients were given three injections at the start of the trial, then at weeks two and four. They were then asked to eat six grams of gluten a day for two weeks, roughly the amount in two slices of bread.

Symptoms stayed in check among patients treated with ANB033 during the gluten challenge. Those given the placebo saw their symptoms worsen.

Study lead Dr Benjamin Lebwohl said: “It is remarkable to see, for the first time, both statistically significant prevention of symptoms and (intestinal) benefit in the same study.”

How does the drug work?

ANB033 targets two immune system proteins, IL-15 and IL-2, which are involved in the inflammation that causes gut damage in coeliac disease.

A strict gluten-free diet remains the main way to manage the condition. But avoiding gluten is not always easy, and even small traces can trigger symptoms and harm the gut.

If further trials back up these results, ANB033 could offer a new option for patients who still face the risk of gluten exposure despite following dietary advice.

There is a long way to go, though. The trial involved just 32 patients, so larger studies will be needed to check how safe the drug is and whether the benefits hold up in more people.

More data due in 2027

Researchers are now assessing gut healing and symptom severity at 12 weeks in a second group of patients. Initial results are expected in early 2027.

Full results are due to be presented at the International Celiac Disease Symposium in Melbourne in November 2026.