A new celiac disease treatment candidate has shown it can blunt the damage that gluten causes in the small intestine, at least in a short and tightly controlled trial. On 12 October 2026, First Tracks Biotherapeutics reported top-line results for ANB033, an injected antibody, from a placebo-controlled Phase 1b study in which 32 evaluable people with celiac disease ate gluten every day for two weeks. According to the company, ANB033 limited intestinal damage and stopped symptoms from rising, compared with placebo.
The data are preliminary, come from a small group and have not yet appeared in a peer-reviewed journal. Below we explain what was tested, what changed, what the safety numbers show, and why the standard of care has not changed yet.
Celiac disease treatment: key takeaways
- ANB033 blocks CD122, a receptor subunit shared by two immune-signalling pathways, IL-15 and IL-2.
- In 32 evaluable patients (17 on ANB033 and 15 on placebo), the drug limited gut-lining damage after a 14-day gluten challenge, as reported by the company.
- Symptom scores did not climb on ANB033 while they rose clearly on placebo.
- No serious adverse events were reported in either group.
- The study is small, short and company-reported, and a strict gluten-free diet remains the mainstay of care.
Why a celiac disease treatment beyond diet is being studied
Celiac disease is an autoimmune condition in which eating gluten damages the lining of the small intestine. As the National Institute of Diabetes and Digestive and Kidney Diseases explains, the main treatment is a strict gluten-free diet. Avoiding gluten completely is demanding in everyday life, and accidental exposure worries many patients, which is why researchers are testing medicines that might protect the gut. Nothing in this study shows that a drug can replace the diet.
How the celiac disease treatment trial was run
The Phase 1b study was randomised and placebo-controlled. Participants received three loading doses under the skin, at weeks 0, 2 and 4, and then took a gluten challenge for 14 days: 6 grams of gluten a day, roughly two slices of bread, given as two gluten cookies. The main analysis was at week 6. The company has not disclosed the dose amount.
Thirty-four people were in the safety analysis (18 on ANB033, 16 on placebo). Thirty-two completed dosing and the challenge and were evaluable: 17 on ANB033 and 15 on placebo. Two others were randomised but left before the challenge and had no week-6 biopsy.
What happened to the gut lining under the celiac disease treatment
The first measure was the ratio of villus height to crypt depth (Vh:Cd). Villi are the tiny finger-like folds that absorb nutrients, and the ratio falls when gluten flattens them. On placebo the ratio fell by an average of 0.66. On ANB033 it fell by 0.17, a difference of 0.49 that the company reports as statistically significant (p=0.009). By our arithmetic, the drop on ANB033 was about a quarter of the drop on placebo.
The second measure was intraepithelial lymphocyte (IEL) density. These immune cells increase in the gut lining when gluten triggers the disease. On placebo, IEL density rose by 18.83 on average, while on ANB033 it changed by -1.20 (p below 0.001). A composite score that combines the readings moved by -3.59 on placebo and -0.25 on ANB033 (p=0.002).
Symptoms and medication use in the celiac disease treatment trial
Participants kept a daily diary covering five symptoms: abdominal pain, bloating, nausea, diarrhoea and tiredness. On placebo, symptoms rose markedly during the challenge. The ANB033 group did not see that increase. The company reports that scores were significantly lower than placebo from day 1 through day 7, and that moderate-to-severe symptoms were significantly lower from day 1 through day 12. Permitted symptom-relief medicines were used by 47% of placebo patients and 6% of those on ANB033.
What the safety data show for this celiac disease treatment
Overall, 94.1% of participants had at least one adverse event: 100% on placebo and 88.9% on ANB033. There were no serious adverse events in either group, and one severe event occurred, on placebo. Moderate events were reported by 75.0% of the placebo group and 16.7% of the ANB033 group. One placebo participant stopped because of an adverse event, and none on ANB033 did. One thing went the other way: injection-site redness was more common with ANB033 (27.8%) than with placebo (12.5%). With groups this small, the figures are a first look, not a safety profile.
Risks and caveats for this celiac disease treatment
- Small and short: 32 evaluable patients and a two-week challenge cannot show how the drug works over months or years.
- The challenge is controlled, so it does not replicate real-world exposure to gluten.
- The dose is undisclosed, and results come from the company rather than a peer-reviewed paper.
- ANB033 reduces some immune-cell populations by design. Longer studies will need to show what that means for infections and other long-term effects.
- Early results often change in larger trials. Forward-looking statements in the release carry the usual warnings, and more detail is available in the company’s filings on the SEC’s EDGAR database.
In our assessment, this is a credible early signal rather than a new standard. Tissue damage and symptoms moved in the same direction, which is encouraging, but the real test of a celiac disease treatment is larger and longer trials.
What to watch next for celiac disease treatment
- Full data at the ICDS meeting in Melbourne in November 2026.
- Top-line results from a second cohort in celiac disease, which tests mucosal healing over 12 weeks without a gluten challenge, expected in the first quarter of 2027.
- A late-stage celiac disease trial, anticipated to start in 2027 after talks with regulators. ANB033 already holds the FDA’s Fast Track designation.
Related reading: our report on an early-stage trial in a different disease, and more drug-development news in pharmaceutical.
Frequently asked questions
What is ANB033, the celiac disease treatment candidate?
An investigational antibody, given under the skin, that blocks CD122 and so dampens IL-15 and IL-2 signalling. It is being developed by First Tracks Biotherapeutics.
Is this celiac disease treatment approved?
No. It is investigational and still in early-stage testing.
Can people with celiac disease eat gluten on this drug?
No such conclusion can be drawn. The study used a short, supervised challenge, and a strict gluten-free diet remains the standard approach.
How many people were studied?
Thirty-two were evaluable, 17 on ANB033 and 15 on placebo, with 34 in the safety analysis.
How we reported this: we relied on First Tracks Biotherapeutics’ announcement of 12 October 2026 and the company’s investor presentation, plus public health information from the NIDDK. Figures labelled as ours are our own arithmetic. Last updated: 15 October 2026. This article is news reporting and not medical advice.