First Tracks Biotherapeutics Jumps 20% After ANB033 Meets Key Celiac Disease Trial Endpoints

First Tracks Biotherapeutics reported positive top-line results from a Phase 1b gluten-challenge study of ANB033 in celiac disease, sending shares up roughly 20% to 25% on Monday morning and drawing 8.89 million shares in pre-market volume.

The drug significantly reduced intestinal damage on two primary measures. On the villus height-to-crypt depth ratio, a key marker of intestinal architecture, patients on ANB033 showed a least-squares mean change from baseline of -0.17 compared with -0.66 on placebo, a placebo-adjusted delta of +0.49 that was statistically significant at p=0.009. On intraepithelial lymphocyte density, a measure of immune-driven gut inflammation, ANB033 produced a change of -1.20 versus +18.83 on placebo, a placebo-adjusted delta of -20.03 with p less than 0.001, meaning the drug prevented the surge in intestinal immune cells that gluten provoked in placebo patients.

The results indicate ANB033 both protected intestinal structure and blunted the inflammatory response to gluten challenge, clearing a meaningful clinical bar at an early stage and supporting further development in celiac disease.