Experimental Drug ANB033 Protects Celiac Patients From Gluten Damage in Early Trial

An experimental drug has shown promising results in shielding the intestines of people with celiac disease from gluten-related damage, according to early trial results released this week. The drug, called ANB033, also prevented symptoms from worsening when patients were deliberately given gluten — an encouraging signal for a condition that currently has no approved drug treatment.

The Phase 1b study was conducted by US-based First Tracks Biotherapeutics; the results were also reported independently by Reuters and the Celiac Disease Foundation. Researchers say the findings could eventually shield patients from the accidental gluten exposure that millions of sufferers live in fear of every day.

FAKTA

• Drug: ANB033, developed by First Tracks Biotherapeutics (United States)
• Trial: Phase 1b, Cohort 1 — 32 patients (17 on the drug, 15 on placebo)
• Design: three subcutaneous injections, followed by 14 days of six grams of gluten daily — about two slices of bread
• Key result: statistically significant protection against intestinal damage (p=0.009)
• Safety: well tolerated; no serious or severe adverse events, no treatment discontinuations
• Next step: the company plans late-stage development in 2027

How the Trial Worked

All participants had been diagnosed at least a year earlier and were following a gluten-free diet, yet pre-trial biopsies showed they still had moderate intestinal damage — a common reality, since even trace gluten exposure causes harm.

Patients received three subcutaneous injections — of ANB033 or a placebo — at the start of the trial, at week two and at week four. They then ate six grams of gluten daily for two weeks, roughly two slices of bread, while doctors tracked damage and symptoms; a second set of biopsies at the end measured the difference precisely.

Protection Against Damage and Symptoms

On the key measure of intestinal health — the villus height-to-crypt depth ratio — the drug group declined by only 0.17 points versus 0.66 for placebo, a statistically significant difference (p=0.009). Inflammation markers fell in the drug group while rising sharply among those on placebo.

The symptom data told the same story. Patients receiving ANB033 experienced no increase in symptoms across the entire gluten challenge, whereas the placebo group reported a marked rise. Only 6 percent of drug-treated patients needed permitted medication for digestive complaints, compared with 47 percent of those on placebo.

What Comes Next

ANB033 blocks two immune proteins — interleukin-15 and interleukin-2 — that drive the inflammatory attack when gluten is present. Rather than breaking down gluten, the drug interrupts the immune system’s destructive response.

First Tracks Biotherapeutics said it will discuss the findings with regulators and aims to begin late-stage development in 2027. Larger trials will be needed to confirm both the benefit and the safety profile before the drug could reach patients. For more health and science coverage, visit Watan News International.