ANB033, a drug being developed by First Tracks Biotherapeutics, not only reduced symptoms from gluten exposure in patients with celiac disease but also demonstrated protection against gluten-induced intestinal damage, according to results of a small early-stage trial.
Participants in the 32-patient study had been diagnosed with celiac disease at least a year prior and were following a gluten-free diet, but still had moderate damage to their intestines as seen on biopsies.
Even trace exposure to gluten can cause intestinal damage and debilitating symptoms despite general adherence to a gluten-free diet, the researchers noted.
Patients were given three subcutaneous injections of First Tracks’ ANB033 or a placebo at the start of the trial, at week 2 and week 4, followed by two weeks of daily consumption of 6 grams of gluten, or about the equivalent of two slices of bread.
A second set of biopsies done at the end of the study showed patients who received the drug had statistically significant protection against intestinal damage compared with those who got a placebo, according to the company, opens new tab.
Furthermore, ANB033 prevented an increase in symptoms throughout the entire gluten challenge, whereas patients in the placebo group experienced a marked increase in symptoms, the researchers found.
Only 6% of ANB033 patients needed permitted medications to mitigate their gastrointestinal symptoms, compared with 47% of placebo patients.
“It is remarkable to see, for the first time, both statistically significant prevention of symptoms and (intestinal) benefit in the same study,” study leader Dr. Benjamin Lebwohl of New York-Presbyterian/Columbia University Irving Medical Center said in a statement.
ANB033 inhibits immune cell proteins IL-15 and IL-2, two key drivers of inflammation that damage the intestine, with IL-2 closely linked to symptom development, Lebwohl noted.
As part of the same trial, the researchers are assessing intestinal healing and symptom severity at 12 weeks in a second group of patients, with initial results expected early next year.
They expect to present the full results of the study at the International Celiac Disease Symposium, in Melbourne, Australia, next month.