First Tracks Biotherapeutics reported what it called positive top-line results from an early-stage trial of its treatment for celiac disease.
The company said Monday its treatment, ANB033, achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms, compared with placebo.
Shares of First Tracks jumped 17%, to $37.36, in premarket trading.
First Tracks Chief Executive Daniel Faga said trace exposure to gluten can cause intestinal damage and debilitating systems for people living with celiac disease.
"After treatment with ANB033, patients underwent a 14-day gluten challenge consuming the equivalent of two slices of bread a day," Faga said. "ANB033 achieved a statistically significant and clinically meaningful protective effect against gluten-induced intestinal damage and symptoms, while maintaining a favorable safety profile."
First Tracks said its treatment prevented an increase in symptoms throughout the entire gluten challenge. Meanwhile, patients receiving placebo experienced a marked increase in symptoms consistent with an intense gluten challenge, it added.
"We look forward to continuing to work with regulators, clinicians and the patient community as we advance ANB033 into late-stage development in 2027," Faga said.