New drug may offer treatment for coeliac disease

An experimental treatment for coeliac disease has shown potential in an early-stage trial, reducing symptoms and helping to prevent gut damage after gluten exposure, its developer said today.

Trial shows gut protection

First Tracks Biotherapeutics ran a small trial involving 32 people. Participants received three injections of the drug: one at the start, then one at week two and one at week four. They then ate six grams of gluten a day for two weeks, roughly the amount in two slices of bread.

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

In terms of specific results, just 6% of patients given ANB033 needed medication to ease gut symptoms during the trial, against 47% of those who received a placebo. Symptoms stayed in check among those treated with the drug, while those given the placebo saw theirs worsen.

ANB033 also significantly reduced gluten-related gut damage compared with the placebo.

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?

The therapy works by targeting two immune system proteins, IL-15 and IL-2. Both 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 was small, so larger studies will be needed to check how safe the drug is and whether the benefits could be seen more widely.

More data due in 2027

The full results from this trial are due to be presented at the International Celiac Disease Symposium in Melbourne in November 2026.

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