By Lew Kizer — 2026-10-21 — Health & Nutrition
The short answer
On October 12, 2026, First Tracks Biotherapeutics reported that its investigational antibody ANB033 reduced intestinal damage and symptoms versus placebo in a Phase 1b celiac trial with a 14-day gluten challenge. Among 32 patients who completed the challenge, the villus height-to-crypt depth ratio fell less on ANB033 (placebo-adjusted difference +0.49, p=0.009). The FDA has granted Fast Track designation, and a late-stage trial is planned for 2027.
Key facts
- Randomized, placebo-controlled Phase 1b; 32 patients completed dosing and challenge (17 drug, 15 placebo).
- Challenge: 6 g of gluten daily for 14 days, about two slices of bread.
- Villus height-to-crypt depth change: −0.17 on ANB033 vs −0.66 on placebo (p=0.009).
- Intraepithelial lymphocytes rose 18.83 on placebo and fell 1.20 on ANB033 (p<0.001).
- 47% of placebo patients vs 6% of ANB033 patients used medicine for GI symptoms.
- No serious adverse events in either group. Results will be presented at ICDS in Melbourne in November.
KINGSPORT, Tenn., Oct. 21, 2026 — Four days after argenx said its celiac drug FB102 met its main goal, a second company reported results for a drug that targets the same immune pathway.
First Tracks Biotherapeutics said on October 12 that ANB033 protected the small intestine and reduced symptoms during a two-week gluten challenge.
This article reports research news and is not medical advice. Talk with your clinician before changing your diet or medicines.
What the trial measured
Adults with celiac disease received three injections of ANB033 or placebo over four weeks, then ate 6 grams of gluten a day for 14 days, about the amount in two slices of bread. Biopsies before and after measured damage to the gut lining.
| Measure (week 6) | Placebo | ANB033 | p-value |
|---|---|---|---|
| Villus height-to-crypt depth ratio change | −0.66 | −0.17 | 0.009 |
| Intraepithelial lymphocyte change | +18.83 | −1.20 | <0.001 |
| Used medicine for GI symptoms | 47% | 6% | — |
Nausea and abdominal pain were far more common on placebo. Injection-site redness was more common on the drug (27.8% vs 12.5%). There were no serious adverse events.
“for the first time, both statistically significant prevention of symptoms and Vh:Cd benefit in the same study” — Benjamin Lebwohl, M.D., Columbia University Irving Medical Center
What comes next
The FDA has granted ANB033 Fast Track designation. First Tracks plans a late-stage celiac trial in 2027, expects results from a second, 12-week cohort in early 2027, and will present the data at the International Celiac Disease Symposium in Melbourne in November. These are company top-line results and have not been peer-reviewed.
Our 2026 celiac treatment pipeline guide compares the leading candidates.
At the table this week
“The average person with celiac disease waits six years for a diagnosis. We exist for those people.” — Lew Kizer, Founder, SmashMeals
If you were recently diagnosed, start with our newly diagnosed celiac meal guide, then see this week's meals.
Commentary, not medical advice
The SmashMeals perspective
Two drugs aimed at the same immune target reported good results in the same month. That is the most encouraging stretch of celiac research news we have seen. It is still company data from small or mid-size trials, and every patient in these studies was living gluten-free before they enrolled. Until a medicine is approved, the diet is the treatment, and we will keep cooking for it.
Frequently asked questions
What is ANB033?
ANB033 is an investigational antibody from First Tracks Biotherapeutics that blocks CD122, part of the receptors for IL-15 and IL-2, immune signals involved in celiac gut damage. It is not approved.
How is ANB033 different from FB102?
Both target CD122. ANB033 is given as an injection under the skin and reported Phase 1b results. FB102, from argenx, is given by IV and reported Phase 2 results on October 8, 2026.
When could a celiac drug be approved?
Not soon. First Tracks plans a late-stage trial in 2027, and argenx plans Phase 3 for FB102. Approval would depend on those results.
Sources and credits
Follow the original sources for context and verification. A reference is not an endorsement of SmashMeals.
- First Tracks Biotherapeutics announces positive top-line results for ANB033 in gluten-challenge study in celiac disease (opens in a new tab)
First Tracks Biotherapeutics via GlobeNewswire
Why it matters: Primary source for the design, numbers and plans.
- argenx announces positive topline results from Phase 2 study of FB102 in celiac disease (opens in a new tab)
argenx
Why it matters: A second anti-CD122 candidate reported Phase 2 results the same month.
- FDA grants Fast Track designation to drug candidate for celiac disease (opens in a new tab)
Pharmacy Times
Why it matters: Context on another IL-15 pathway candidate, Teva's TEV-53408.