An experimental drug called ANB033, being developed by First Tracks Biotherapeutics, eased flare-ups triggered by gluten in people with celiac disease and also shielded their intestines from gluten-induced harm, according to results of a small early-stage trial.
The study enrolled 32 patients who had received a celiac diagnosis at least a year earlier. They were keeping to a gluten-free diet, yet biopsies still showed moderate intestinal damage. Researchers noted that even trace amounts of gluten can injure the gut and cause disabling symptoms, despite general adherence to such a diet.
How the ANB033 trial tested gluten exposure
Participants received three subcutaneous injections, either ANB033 or a placebo, at the start of the trial and at weeks 2 and 4. They then ate 6 grams of gluten every day for two weeks, roughly equal to two slices of bread.
A second set of biopsies at the end of the study indicated that patients who got the drug had statistically significant defence for their intestines against harm, compared with placebo recipients, the company said. The researchers also found that ANB033 stopped symptoms from rising during the entire gluten challenge, while placebo patients experienced a sharp increase.
Only 6% of patients taking ANB033 needed permitted medications to manage gastrointestinal symptoms, compared with 47% of those on placebo.
Mechanism and next steps for the ANB033 study
Study leader Dr. Benjamin Lebwohl of New York-Presbyterian/Columbia University Irving Medical Center described it as a first to see both statistically significant symptom prevention and intestinal benefit in the same study. Lebwohl also said ANB033 inhibits the immune cell proteins IL-15 and IL-2, both major drivers of gut-damaging inflammation, with IL-2 closely tied to symptom development.
In a second group within the same trial, researchers are assessing intestinal healing and symptom severity at 12 weeks, with initial results expected early next year. The full findings are expected to be presented at the International Celiac Disease Symposium in Melbourne, Australia, next month.
