First Tracks Biotherapeutics stock surges 20% on celiac trial data

Investing.com -- First Tracks Biotherapeutics (NASDAQ: TRAX) shares surged 20% Monday after the company announced positive top-line results from its Phase 1b trial evaluating ANB033 in celiac disease.

The study showed ANB033 achieved statistically significant results compared to placebo across key endpoints. The treatment demonstrated a least squares mean change from baseline in villus height-to-crypt depth ratio of -0.17 on ANB033 versus -0.66 on placebo, representing a +0.49 placebo-adjusted delta (p=0.009). For intraepithelial lymphocyte density, ANB033 showed a least squares mean change of -1.20 compared to +18.83 on placebo, a -20.03 placebo-adjusted delta.

The trial evaluated 32 patients in Cohort 1, with 17 receiving ANB033 and 15 receiving placebo. Patients underwent a 14-day gluten challenge consuming 6g of gluten daily, equivalent to approximately two slices of bread.

ANB033 prevented an increase in symptoms throughout the gluten challenge, with lower Celiac Disease Symptom Diary scores versus placebo that were statistically significant from the first day. The treatment showed 47% of placebo patients took permitted medications to mitigate gastrointestinal symptoms compared to only 6% of ANB033 patients.

The drug demonstrated a favorable safety profile with no serious adverse events, no severe adverse events, and no adverse events leading to discontinuation reported in the ANB033 group.

First Tracks Biotherapeutics plans to engage with regulatory agencies, including the FDA which has granted ANB033 Fast Track designation, to discuss the next phase of development. The company anticipates starting a late-stage clinical trial in celiac disease in 2027.

Cohort 2 of the Phase 1b trial is expected to complete enrollment imminently, with top-line data anticipated in the first quarter of 2027.

Original Article

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