First Tracks Biotherapeutics reports positive Phase 1b results for ANB033 in celiac disease
First Tracks Biotherapeutics (TRAX) presented top‑line data from Cohort 1 of its Phase 1b ANB033 trial in celiac disease on Oct 12, 2026. The antibody showed statistically significant improvements in villus height‑to‑crypt depth ratio, intra‑epithelial lymphocyte density and patient‑reported symptoms versus placebo, with no serious safety signals. The company said it will discuss the findings with regulators and plans to start a late‑stage trial in 2027.
Why it matters
The positive data suggest ANB033 may become the first approved therapy for celiac disease, a market with no approved drugs, potentially expanding First Tracks' revenue base. The company’s share price jumped about 20% after the release, reflecting investor optimism.
Key facts
- 1The Phase 1b Cohort 1 trial enrolled 32 patients, with 17 receiving ANB033 and 15 receiving placebo. stocktitan.net
- 2ANB033 produced a least‑squares mean change in villus height‑to‑crypt depth ratio of -0.17 versus -0.66 for placebo, a placebo‑adjusted delta of +0.49 (p=0.009). stocktitan.net
- 3Intra‑epithelial lymphocyte density changed by -1.20 on ANB033 versus +18.83 on placebo, a placebo‑adjusted delta of -20.03 (p<0.001). stocktitan.net
- 4No serious adverse events, severe adverse events, or discontinuations were reported in the study. finance.yahoo.com
- 5Shares rose roughly 20% in pre‑market trading after the results were released. investing.com
- 6The FDA has previously granted Fast Track designation to ANB033 for celiac disease. rttnews.com
Summary written by AlphAI AI Desk from 9 of 9 sources. Not investment advice. Figures are as stated by the linked sources.