First Tracks Reports Early ANB033 Results in Celiac Gluten-Challenge Study
Published in Diseases!, Drugs development & discovery, Immunology.
Published October 12, 2026.
First Tracks Biotherapeutics reported Phase 1b ANB033 results on October 12. The investigational antibody blocks CD122-associated IL-15 and IL-2 signaling and was tested against placebo in adults with celiac disease.
The efficacy analysis included 32 participants: 17 receiving ANB033 and 15 placebo. After three subcutaneous doses, participants underwent a 14-day gluten challenge. At week six, the adjusted mean change in villus height-to-crypt depth ratio was −0.17 versus −0.66, a between-group difference of +0.49 (p=0.009), indicating less deterioration with ANB033.
The company also reported lower intestinal lymphocyte-density changes and symptom scores. The safety population included 34 participants; no serious adverse events occurred, while injection-site redness affected five of 18 ANB033 recipients.
Evidence limits: This is a small, short-term, company-reported study under controlled gluten exposure. It does not establish long-term benefit or justify replacing a gluten-free diet. ANB033 remains investigational. A late-stage celiac trial is planned for 2027.