FB102 trial reportedly finds less gluten-related intestinal damage in celiac disease

A controlled gluten challenge involving 126 participants

ScienceAlert reported that argenx announced positive topline results from a Phase 2 randomized, blinded trial of FB102. The trial enrolled 126 symptom-free participants with confirmed celiac disease who had followed a strict gluten-free diet for at least a year. During an eight-week oral gluten challenge, participants received either intravenous FB102 or placebo. At day 78, the reported results found better preservation of the intestinal mucosal lining and a smaller inflammatory immune response among those receiving FB102.

The source says there is currently no approved drug to protect the gut from accidental gluten exposure in people with celiac disease.

According to the reported topline Phase 2 results, FB102 recipients had better preservation of the intestinal lining and less mucosal inflammation than placebo recipients during the controlled gluten challenge.

The reported result concerns protection from gluten-induced intestinal damage under controlled trial conditions, an unmet need for which the source says no approved therapy exists. It does not establish real-world protection or that people with celiac disease can consume gluten without care; the company says it supports advancing FB102 to Phase 3 development.