The Netherlands-based Argenx SE (Euronext & Nasdaq: ARGX) reported positive Phase II results for FB102, an anti-CD122 antibody, in adults with celiac disease, with the trial meeting its primary endpoint of reduced gluten-induced intestinal damage. The company plans to advance the drug into Phase III development.
The 126-patient FB102-301 trial (NCT06982963) demonstrated a statistically significant improvement over placebo in the ratio of villus height to crypt depth, a measure of intestinal damage, following an eight-week gluten challenge (p=0.0176). Argenx reported supportive findings across other measures of intestinal inflammation and symptoms, with no new safety signals, but did not disclose detailed efficacy or safety data.
The results mark a significant milestone for FB102 following argenx's USD 2.2 billion acquisition of Forte Biosciences in August 2026. FB102 targets CD122, a component of IL-2 and IL-15 signaling, and is also being developed for vitiligo, where Forte reported positive Phase Ib results in July.
The readout follows positive Phase IIa results reported by Teva Pharmaceutical Industries (NYSE: TEVA) in September for TEV-'408, an anti-IL-15 antibody that also significantly reduced gluten-induced intestinal damage. Both programs target the IL-15 inflammatory pathway, an emerging therapeutic approach for celiac disease, which currently has no approved drug treatments.