First Tracks Biotherapeutics Announces Positive Top-Line Results for ANB033 in Gluten-Challenge Study in Celiac Disease
Key Highlights
- ➤ANB033 Vh:Cd ratio placebo-adjusted delta +0.49, p=0.009
- ➤ANB033 IEL density placebo-adjusted delta -20.03, p<0.001
- ➤ANB033 prevented symptom increases; differences were significant from day one
- ➤ANB033 had no serious adverse events or treatment discontinuations
- ➤Cohort 2 top-line data expected Q1 2027; late-stage trial planned for 2027
Expert Statements
Daniel Faga, President and Chief Executive Officer of First Tracks Biotherapeutics
“For people living with celiac disease, trace exposure to gluten can cause intestinal damage and debilitating symptoms despite general adherence to a gluten-free diet. After treatment with ANB033, patients underwent a 14-day gluten challenge consuming the equivalent of two slices of bread a day. ANB033 achieved a statistically significant and clinically meaningful protective effect against gluten-induced intestinal damage and symptoms, while maintaining a favorable safety profile. We look forward to continuing to work with regulators, clinicians and the patient community as we advance ANB033 into late-stage development in 2027.”
Benjamin Lebwohl, M.D., MS, Professor of Medicine and Epidemiology at NY-Presbyterian/Columbia University Irving Medical Center and Director of Clinical Research at the Celiac Disease Center at Columbia University
“It is remarkable to see, for the first time, both statistically significant prevention of symptoms and Vh:Cd benefit in the same study. Equally impressive, ANB033 showed changes from baseline that remained below the threshold considered clinically meaningful in an intense gluten challenge. ANB033 takes a novel approach to treating celiac disease by targeting CD122 and blocking both IL-15 and IL-2 signaling, two key drivers of inflammation that damage the intestine, with IL-2 closely linked to symptom development. For the largest autoimmune disease without an approved therapeutic option, these findings are an important advance for the celiac disease community.”
Paul Lizzul, M.D., Ph.D., Chief Medical Officer of First Tracks Biotherapeutics
“The consistency of the histologic and symptom findings strengthens our confidence in the underlying biology and supports continued development of ANB033 in celiac disease and other conditions driven by this pathway, including eosinophilic esophagitis and vitiligo. We are deeply grateful to the patients, investigators and study teams who made this important milestone possible and look forward to presenting these results at ICDS in Melbourne in November.”
* ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms * LS mean change from baseline in Vh:Cd ratio of -0.17 on ANB033 vs. -0.66 on placebo, a +0.49 placebo-adjusted delta (p=0.009) * LS mean change from baseline in IEL density of -1.20 on ANB033 vs. +18.83 on placebo, a -20.03 placebo-adjusted delta (p<0.001) * Prevented an increase in symptoms throughout the entire gluten challenge, with lower CDSD score on ANB033 vs. placebo that was statistically significant from the first day * Well tolerated with no safety signals observed to date * Conference call and webcast today, Monday, Oct. 12, 2026, at 8:30 a.m. ET to discuss these results SAN DIEGO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today announced positive top-line results from Cohort 1 (gluten challenge) of ANB033’s Phase 1b trial in celiac disease (CeD). ANB033, an investigational, subcutaneously administered CD122 antagonist, is designed to inhibit the signaling of both IL-15 and IL-2 on immune cells.
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