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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 \u200cintestinal damage, according to results of a small early-stage trial.<\/strong><\/p>\n 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.<\/p>\n Even trace exposure to gluten can cause intestinal damage and debilitating symptoms despite general adherence to a gluten-free diet, the researchers noted.<\/p>\n Patients were given three subcutaneous injections of First Tracks\u2019 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 \u200bthe equivalent of two slices of bread.<\/p>\n 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 \u200bthe company, opens new tab.<\/p>\n 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.<\/p>\n Only 6% of ANB033 patients \u2060needed permitted medications to mitigate their gastrointestinal symptoms, compared with 47% of placebo patients.<\/p>\n \u201cIt is remarkable to see, for the first time, both statistically significant prevention of symptoms and (intestinal) benefit in the same study,\u201d study leader Dr. Benjamin Lebwohl of New York-Presbyterian\/Columbia University \u200bIrving Medical Center said in a statement.<\/p>\n 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.<\/p>\n As part of the same trial, the researchers are assessing intestinal healing and \u200bsymptom severity at 12 weeks in a second group of patients, with initial results expected early next year.<\/p>\n They expect to present the full results of the study at the International Celiac Disease Symposium, in Melbourne, Australia, next month.<\/p>\n<\/div>\n