First Tracks Biotherapeutics (NASDAQ:TRAX) shares surged 20% on Monday after the biotechnology company reported positive top-line results from a Phase 1b clinical trial evaluating its investigational treatment ANB033 in patients with celiac disease.
The study demonstrated statistically significant improvements across key measures of intestinal damage and disease symptoms compared with placebo, supporting further clinical development of the therapy.
The trial’s first cohort included 32 patients, with 17 receiving ANB033 and 15 assigned to placebo.
Participants underwent a 14-day gluten challenge, consuming six grams of gluten daily, equivalent to approximately two slices of bread, to assess the treatment’s ability to protect against gluten-induced intestinal damage and associated symptoms.
According to the company, ANB033 demonstrated a statistically significant benefit in the villus height-to-crypt depth ratio, a measure used to assess structural changes in the small intestine associated with celiac disease.
Patients receiving ANB033 recorded a least squares mean change from baseline of -0.17, compared with -0.66 in the placebo group.
The difference represented a placebo-adjusted improvement of 0.49, with a p-value of 0.009, indicating statistical significance.
The treatment also demonstrated improvements in intraepithelial lymphocyte density, another measure of intestinal inflammation and immune activity.
Patients treated with ANB033 recorded a least squares mean change of -1.20, compared with an increase of 18.83 among placebo recipients, resulting in a placebo-adjusted difference of -20.03.
The findings suggest that ANB033 may help limit the intestinal damage and inflammatory response associated with gluten exposure in patients with celiac disease.
In addition to the tissue-based measurements, the company reported improvements in patient-reported symptoms during the gluten challenge.
ANB033 prevented an increase in symptoms throughout the 14-day exposure period, with patients receiving the treatment recording lower Celiac Disease Symptom Diary scores than those receiving placebo.
The difference was statistically significant from the first day of the gluten challenge, according to the company.
Use of permitted medications to relieve gastrointestinal symptoms was also lower among patients receiving ANB033.
Approximately 47% of participants in the placebo group required symptom-relief medication, compared with 6% of patients treated with ANB033.
The company said the investigational therapy demonstrated a favourable safety profile during the study.
No serious adverse events, severe adverse events or adverse events leading to treatment discontinuation were reported among patients receiving ANB033.
Celiac disease is an autoimmune condition in which gluten consumption triggers an immune response that damages the lining of the small intestine.
The condition is currently managed primarily through a strict gluten-free diet, although accidental exposure can still cause symptoms and intestinal inflammation.
First Tracks Biotherapeutics intends to engage with regulatory authorities, including the US Food and Drug Administration (FDA), to discuss the next stage of ANB033’s clinical development.
The FDA has previously granted Fast Track designation to ANB033, a status intended to facilitate the development and review of treatments addressing serious conditions with unmet medical needs.
The company anticipates initiating a late-stage clinical trial in celiac disease during 2027, subject to regulatory discussions and development planning.
Meanwhile, enrolment in the second cohort of the ongoing Phase 1b study is expected to conclude shortly, with top-line results anticipated in the first quarter of 2027.
Although the initial findings provide encouraging evidence of biological activity and symptom improvement, the study involved a relatively small patient population.
Larger clinical trials will be needed to confirm the treatment’s efficacy, establish its longer-term safety profile and determine whether the results can support a future regulatory application.