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First Tracks Biotherapeutics reports positive Phase 1b data for ANB033 in celiac disease
TRAXFirst Tracks Biotherapeutics, Inc.
First Tracks Biotherapeutics announced positive top-line results from the first cohort of its Phase 1b trial for ANB033, an investigational CD122 antagonist, in patients with celiac disease. The study demonstrated that ANB033 achieved statistically significant and clinically meaningful protective effects against gluten-induced intestinal damage and symptoms compared to placebo during a 14-day gluten challenge. Key histologic endpoints showed a +0.49 placebo-adjusted delta in the villus height-to-crypt depth ratio (p=0.009) and a -20.03 delta in intraepithelial lymphocyte density (p<0.001). The treatment was well-tolerated with no serious adverse events observed. The company plans to engage with regulators regarding late-stage development, anticipating the start of a Phase 3 trial in celiac disease in 2027. First Tracks Biotherapeutics is a clinical-stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases.