• 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.

ANB033 demonstrated a statistically significant difference compared to placebo across key histologic endpoints, including least squares (LS) mean change in villus height-to-crypt depth (Vh:Cd) ratio, intraepithelial lymphocyte (IEL) density, and VCIEL composite scale, as well as symptom endpoints using the Celiac Disease Symptom Diary (CDSD). 

In the context of an intense gluten challenge, treatment with ANB033 not only prevented an increase in IEL density, but also protected against gluten-induced intestinal damage with changes in Vh:Cd ratio remaining below the threshold considered clinically meaningful.