First Tracks Biotherapeutics announced positive top-line results from the first cohort of its Phase 1b clinical trial for ANB033, an investigational treatment for Celiac Disease. The study demonstrated that ANB033 achieved statistically significant and clinically meaningful protective effects against both gluten-induced intestinal damage and symptoms in patients undergoing a gluten challenge.
Key Details
- Primary Efficacy: The trial met key histologic endpoints, including a +0.49 placebo-adjusted improvement in the villus height-to-crypt depth (Vh:Cd) ratio (p=0.009) and a -20.03 placebo-adjusted delta in intraepithelial lymphocyte (IEL) density (p<0.001).
- Symptom & Safety: ANB033 prevented an increase in symptoms throughout the 14-day gluten challenge and was well-tolerated with no serious adverse events observed.
- Next Steps: The company plans to advance ANB033 into late-stage development, anticipating the start of a new trial in 2027. Top-line data from the study's second cohort is expected in Q1 2027.