European immunology company argenx SE (EBR & NASDAQ: ARGX) on Thursday reported positive top-line results from a Phase 2 study of FB102, a first-in-class CD122 inhibitor, in adults with coeliac disease.

FB102 achieved a statistically significant and clinically relevant treatment effect versus placebo, meeting the primary endpoint of change from baseline in the villus height-to-crypt depth ratio at day 78 during an eight-week gluten challenge (p=0.0176). Additional efficacy measures, including intraepithelial lymphocyte density, a composite VCIEL score, and symptoms, aligned with the primary endpoint across histologic, inflammatory, and clinical assessments.

The safety profile was consistent with earlier studies and showed no new safety signals.

The randomised, double-blind Phase 2 study enrolled 126 adults with confirmed coeliac disease who had followed a strict gluten-free diet for at least 12 months. Participants received two dose levels of FB102 or placebo during a controlled gluten challenge, with the primary endpoint assessing protection against gluten-induced intestinal damage.

FB102 is an investigational anti-CD122 antibody designed to modulate IL-2 and IL-15 signalling pathways implicated in autoimmune disease, and has Fast Track designation from the US Food and Drug Administration for coeliac disease. argenx plans to advance FB102 into Phase 3 development and continue evaluating its potential in other autoimmune conditions such as vitiligo and alopecia areata.