Skip to main content
Signal8

First Tracks Biotherapeutics Announces Positive Top-Line Results for ANB033 in Gluten-Challenge Study in Celiac Disease

$TRAXPress releaseOct 12, 2026, 7:00 AM ETRead the release

First Tracks Biotherapeutics reported positive top-line results from Cohort 1 of ANB033's Phase 1b celiac disease trial, with statistically significant protection against gluten-induced intestinal damage and symptoms versus placebo. Vh:Cd ratio change was -0.17 on ANB033 versus -0.66 on placebo (p=0.009), and IEL density fell -1.20 versus +18.83 on placebo (p<0.001); ANB033 also blunted symptoms from day one of the 14-day gluten challenge with no serious adverse events.

Key figures

Drug Name
ANB033
Phase Of Trial
Phase 1b
Eoe data
Q3 2027
Cohort2 data
Q1 2027
Cohort1 patients
32
Gluten challenge
14-day, 6g daily
Eoe cohort patients
50
Vciel ls mean change
-0.25 ANB033 vs -3.59 placebo (delta +3.33, p=0.002)
Vh cd ls mean change
-0.17 ANB033 vs -0.66 placebo (delta +0.49, p=0.009)
Iel density ls mean change
-1.20 ANB033 vs +18.83 placebo (delta -20.03, p<0.001)

AI analysis

Red flags2 · Pro

The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.

AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.