First Tracks Biotherapeutics, Inc. (NASDAQ:TRAX) on Monday released topline results from Cohort 1 of its Phase 1b clinical trial of ANB033 in celiac disease.
Following the announcement, the stock jumped more than 13%.
The clinical-stage biotechnology firm designed ANB033 as an investigational, subcutaneously administered CD122 antagonist to block IL-15 and IL-2 signaling on immune cells.
During a 14-day gluten challenge, the candidate protected against gluten-induced intestinal damage and prevented symptom aggravation in study subjects.
Coeliac disease is a chronic autoimmune condition where eating gluten damages the lining of the small intestine.
Key Histologic and Symptom Milestones Reached
The study evaluated 32 patients, with 17 receiving ANB033 and 15 receiving placebo.
Participants received three subcutaneous loading doses at weeks zero, two, and four before embarking on a daily 6-gram gluten challenge administered via two cookies.
ANB033 met all key histologic efficacy endpoints at Week 6, demonstrating statistically significant benefits over placebo in villus height-to-crypt depth ratio change, intraepithelial lymphocyte density, and the VCIEL composite scale.
Substantial Relief From Gastrointestinal Symptoms
In addition to protecting gut histology, ANB033 controlled daily symptoms recorded through the Celiac Disease Symptom Diary, which tracks abdominal pain, bloating, nausea, diarrhea, and fatigue.
Patients receiving ANB033 showed statistically significant reductions in total symptom scores from days one to seven and lower moderate-to-severe symptoms from days one to twelve.
Additionally, only 6% of ANB033 patients utilized permitted medications for gastrointestinal relief, compared to 47% of placebo participants.
Favorable Safety and Upcoming Catalysts
ANB033 demonstrated solid safety and tolerability with zero serious adverse events, severe adverse events, or treatment discontinuations.
First Tracks Biotherapeutics will align with regulatory agencies to prepare for a late-stage celiac trial in 2027.
Cohort 2, which measures mucosal healing over 12 weeks, will complete enrollment imminently, with topline results expected in the first quarter of 2027.
Furthermore, the company anticipates data from a 50-patient Phase 1b eosinophilic esophagitis trial in the third quarter of 2027 and plans to start Phase 2 trials in vitiligo and another indication in the first half of 2027.
TRAX Price Action: First Tracks shares were up 13.09% at $36.02 during premarket trading on Monday, according to Benzinga Pro data.
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