First Tracks reports ANB033 celiac trial results

• First Tracks Biotherapeutics (NASDAQ:TRAX) reported statistically significant intestinal and symptom benefits for ANB033 in a Phase 1b celiac disease gluten-challenge cohort.
• Among 32 efficacy-evaluable patients, ANB033 improved intestinal damage measures compared with placebo after six weeks, with a villus height-to-crypt depth ratio difference of +0.49.
• First Tracks Biotherapeutics said it plans a late-stage celiac disease trial in 2027 and expects additional Cohort 2 data in Q1 2027.

First Tracks Biotherapeutics (NASDAQ:TRAX) reported Phase 1b results for ANB033, showing statistically significant changes in intestinal damage and immune-cell measurements during a gluten-challenge study in patients with celiac disease.

The study found that the Week 6 villus height-to-crypt depth ratio change was -0.17 for ANB033 compared with -0.66 for placebo, resulting in a +0.49 difference with a p-value of 0.009.

The company reported that intestinal immune-cell density changed by -1.20 with ANB033 compared with +18.83 for placebo, while the combined tissue score difference was +3.33, with a p-value of 0.002.

First Tracks said ANB033 prevented symptom increases during the 14-day gluten challenge, with statistically significant symptom-score differences reported from days 1 through 7.

The company is developing ANB033 as a potential treatment for celiac disease and expects to advance toward a late-stage clinical trial in 2027, while Cohort 2 topline results are expected in the first quarter of 2027.