---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-419761"
form_type: "8-K"
ticker: "TRAX"
cik: "0002091349"
company_name: "First Tracks Biotherapeutics, Inc."
filed_at: "2026-10-13T12:32:55+00:00"
generated_at: "2026-10-13T12:35:05.723177+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# First Tracks' ANB033 hits Phase 1b celiac endpoints; Vh:Cd delta +0.49 (p=0.009), IEL density -20.03 (p<0.001)

## Summary
- Vh:Cd LS mean change -0.17 on ANB033 vs -0.66 on placebo (placebo-adjusted +0.49, p=0.009); IEL density -1.20 vs +18.83 (-20.03, p<0.001).
- Cohort 1 enrolled 32 patients (17 ANB033, 15 placebo) with a 14-day gluten challenge of 6g daily, about two slices of bread.
- Symptoms suppressed throughout the challenge; 6% of ANB033 patients took rescue GI meds vs 47% on placebo; CDSD benefit significant from day 1.
- Safety: no SAEs, no severe AEs, no discontinuations on ANB033; moderate AEs 16.7% vs 75.0% placebo; nausea 5.6% vs 43.8%; injection site erythema 27.8%.
- Next: Cohort 2 mucosal healing topline Q1 2027, EoE cohort of 50 patients Q3 2027, late-stage celiac trial in 2027; FDA Fast Track already granted.

## SEC filing metadata
- accession: 0001193125-26-419761
- form_type: 8-K
- ticker: TRAX
- cik: 0002091349
- company_name: First Tracks Biotherapeutics, Inc.
- filed_at: 2026-10-13T12:32:55+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2091349/000119312526419761/0001193125-26-419761-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2091349/000119312526419761/trax-20261012.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-419761
- JSON: https://secwatch.observer/filing/0001193125-26-419761.json
- Plain text: https://secwatch.observer/filing/0001193125-26-419761.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.