First Tracks Biotherapeutics Reports Positive Phase 1b Celiac Disease Data

Oct 12, 11:00 AM UTCBullishMedium impact

First Tracks Biotherapeutics, Inc. (TRAX) announced positive top-line results from Cohort 1 of its Phase 1b clinical trial evaluating ANB033 in patients with celiac disease. The six-week study tested the subcutaneously administered drug during a 14-day gluten challenge. ANB033 achieved statistically significant improvements compared to placebo across key histologic and symptom endpoints, preventing increases in intraepithelial lymphocyte density and protecting patients from gluten-induced intestinal damage.

The trial showed that treatment with ANB033 kept key markers of intestinal damage below clinically meaningful threshold levels despite a daily gluten exposure equivalent to approximately two slices of bread. Patients receiving ANB033 also reported significantly fewer digestive symptoms, with only 6% requiring symptom-relieving medications compared to 47% in the placebo group. The therapy was well tolerated, with no serious or severe adverse events observed.

The company plans to consult with regulatory agencies to align on advancing ANB033 into late-stage clinical development in 2027. Investors can also expect top-line results from Cohort 2 of the trial in the first quarter of 2027, as well as Phase 1b results for eosinophilic esophagitis in the third quarter of 2027.

Key points

First Tracks Biotherapeutics reported positive top-line Cohort 1 Phase 1b trial results for ANB033 in celiac disease.
ANB033 protected patients against gluten-induced intestinal damage and significantly reduced digestive symptoms compared to placebo.
Only 6% of patients treated with ANB033 needed symptom-relieving medication during the gluten challenge versus 47% on placebo.
The therapy was well tolerated with no serious or severe adverse events reported.
The company plans to launch a late-stage clinical trial for ANB033 in celiac disease in 2027.

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Questions and answers

What were the key results of the ANB033 Phase 1b celiac disease trial?

ANB033 achieved statistically significant reductions in intestinal damage and symptoms compared to placebo during a 14-day gluten challenge. Only 6% of ANB033 patients required symptom relief medications versus 47% on placebo, with no serious adverse events reported.

How does ANB033 work in treating celiac disease?

ANB033 is a subcutaneously administered CD122 antagonist designed to inhibit both IL-15 and IL-2 signaling pathways. This reduces inflammatory immune cells and helps protect the intestine from gluten-induced damage and associated symptoms.

When will First Tracks Biotherapeutics start late-stage trials for ANB033?

First Tracks Biotherapeutics plans to discuss alignment with regulatory authorities and start a late-stage clinical trial for ANB033 in celiac disease in 2027. Top-line data from Cohort 2 is expected in the first quarter of 2027.