First Tracks Biotherapeutics reported on October 12 that its experimental celiac disease drug ANB033 produced a statistically significant improvement on a measure of protection of the intestinal lining against gluten-induced damage, compared with placebo after six weeks of treatment. The drug also met its marks on other evaluations of disease severity and prevented an increase in symptoms during a gluten challenge, the company said.
The trial enrolled 32 participants, randomized to placebo or three subcutaneous doses of ANB033 over four weeks, followed by a two-week gluten challenge equivalent to about two slices of bread a day. There were no treatment-related serious adverse events and no side effects that led participants to stop treatment. First Tracks expects data from a second cohort in the first quarter of 2027 and plans to start a late-stage trial in 2027.
ANB033 blocks CD122, a receptor component shared by the immune proteins IL-2 and IL-15. It is not alone in that mechanism or in celiac disease: argenx has a CD122-targeting therapy acquired in a recent buyout, and Teva has an IL-15 focused candidate, and both have already shown promise in early celiac trials. A Leerink Partners analyst called the First Tracks results impressive on clean safety and said the data compare favorably with what Teva disclosed last month, while noting the drugs have not been tested head to head.
The company is also running a Phase 1b trial of ANB033 in eosinophilic esophagitis, with data expected in the third quarter of 2027, and plans Phase 2 starts in vitiligo and one further indication in the first half of 2027. That breadth is why analysts describe the drug as a pipeline in a product. The caution is the usual one for a 32-patient study: effect sizes shrink as trials get larger, and celiac has a long history of early promise that did not survive Phase 3.