Health · Pharma & Biotech · 20 hrs ago
First Tracks reports promising early results for celiac drug
First Tracks Biotherapeutics reported promising early results for its experimental celiac drug, ANB033.
The small trial included 32 people who received the drug or a placebo.
After treatment, participants ate gluten for two weeks, and ANB033 reduced signs of damage and prevented a rise in symptoms compared with placebo.
Celiac disease is an immune disorder in which gluten prompts the body to attack the small intestine, and a strict gluten-free diet is currently used to avoid harm.
The findings could point to another option beyond diet, but the early results need confirmation in larger studies.
The company reported no serious treatment-related side effects, and no participants left the trial because of side effects.
First Tracks plans to share more trial results in early 2027 and begin a late-stage trial that year.
First Tracks Biotherapeutics reported positive early-stage results for its experimental celiac disease drug, ANB033.
Compared with placebo, the drug significantly improved a measure of protection against gluten-related damage to the intestinal lining after six weeks.
The company said the drug also met other disease-severity measures and prevented symptoms from increasing during a gluten challenge.
No serious treatment-related adverse events or side effects leading participants to leave the trial were reported.
First Tracks plans to report results from a second study cohort in the first quarter of 2027 and expects to begin a late-stage trial that year.
- Who
- First Tracks Biotherapeutics reported results for its experimental drug, ANB033.
- What
- The drug showed positive early-stage results in a trial for celiac disease.
- When
- The results were reported on Oct. 12, 2026.
- Where
- Not stated
- Why
- The study tested whether ANB033 could reduce signs and symptoms of celiac disease.
This story does not have two clearly opposing sides.
Trial participants completed four weeks of treatment with placebo or one of three subcutaneous doses of ANB033.
Participants underwent a gluten challenge equivalent to eating about two slices of bread each day.
First Tracks reported positive early-stage results, and its shares climbed about 7% in Monday trading.
First Tracks expects to report data from a second study cohort.
First Tracks expects to start a late-stage trial.
- Trial participants
- 32
- Treatment period
- Four weeks
- Gluten challenge
- Two weeks, equivalent to about two slices of bread each day
- Study measures
- ANB033 achieved statistical significance on three measures assessing biological signs of celiac disease
- Safety
- No serious treatment-related adverse events or side effects that led drug recipients to leave the trial were reported
- Share movement
- About 7% rise in Monday trading
What people are saying
We view ANB033 as having pipeline-in-a-product potential across several autoimmune diseases
Celiac disease is the largest autoimmune disease without an approved treatment
new layer of protection beyond the gluten-free diet
Sources
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