First Tracks Biotherapeutics reported positive early-stage results for its experimental celiac drug ANB033. In a 32-patient trial, the drug produced a statistically significant improvement on a measure of intestinal lining protection compared with placebo after a two-week gluten challenge. The drug also met other evaluations of disease severity and prevented an increase in symptoms during the challenge.
No serious treatment-related adverse events or discontinuations were reported. Leerink Partners analyst David Risinger called the initial results "impressive" and said the data compare "favorably" to results Teva Pharmaceuticals disclosed last month. First Tracks' shares climbed about 7% in Monday trading.
ANB033 blocks CD122, a receptor component used by the immune-regulating proteins IL-2 and IL-15. Argenx's celiac therapy also targets CD122, while Teva's drug targets IL-15 specifically. First Tracks expects to report data from a second study cohort in the first quarter of 2027 and to start a late-stage trial in 2027. The company is also testing the drug in eosinophilic esophagitis and plans Phase 2 development in vitiligo and another indication.