SAN DIEGO, California — October 11, 2026
First Tracks Biotherapeutics, Inc. announced that it will report top-line results from Cohort 1 of the global Phase 1b clinical trial of ANB033, an investigational CD122 antagonist being developed for celiac disease. The company scheduled an investor conference call and live webcast for October 12, 2026, at 8:30 a.m. Eastern Time to review findings from a gluten-challenge study designed to assess whether ANB033 can prevent intestinal mucosal damage following gluten exposure. The data are expected to be shared in a separate company press release and discussed during the webcast. ANB033 is an antibody-based therapy designed to modulate immune signaling through CD122, a component of receptors involved in interleukin-2 and interleukin-15 pathways. These pathways are relevant to immune responses implicated in celiac disease, an autoimmune condition triggered by gluten in genetically susceptible individuals. The planned announcement represents an important clinical milestone for First Tracks Biotherapeutics as it evaluates a potential new approach to managing immune-mediated intestinal injury. Top-line efficacy and safety results were not included in the October 11 announcement, and conclusions about ANB033’s clinical performance should await the actual data release.
Phase 1b Trial Evaluates ANB033 in Celiac Disease
The Phase 1b trial is evaluating ANB033 in a gluten-challenge setting, with Cohort 1 specifically designed to assess prevention of mucosal damage. In celiac disease, gluten exposure can activate abnormal immune responses that damage the small intestine’s lining, potentially impairing nutrient absorption and contributing to gastrointestinal and systemic symptoms. A controlled gluten challenge can help researchers evaluate whether an investigational treatment reduces the biological effects of gluten exposure. According to First Tracks, the global Phase 1b study is assessing ANB033 as a potential therapeutic approach for this disease. The company’s October 11 announcement focused on the timing and format of the upcoming data presentation rather than providing numerical clinical outcomes, participant numbers or detailed safety findings. Consequently, the magnitude of any treatment effect, the statistical significance of the results and the incidence of adverse events cannot be determined from this announcement. The forthcoming top-line results are expected to provide the first information discussed in the planned investor webcast about the Cohort 1 gluten-challenge assessment.
CD122 Antagonism Targets Immune Pathways in Celiac Disease
ANB033 is an investigational CD122 antagonist designed to modulate immune pathways involved in autoimmune and inflammatory diseases. CD122 is the beta chain shared by receptors for interleukin-2 and interleukin-15, cytokines that regulate immune-cell activity. In celiac disease, immune responses to gluten can lead to intestinal inflammation and tissue damage, making targeted immune modulation an area of clinical investigation. By targeting CD122, ANB033 is intended to interfere with relevant immune signaling rather than simply address symptoms. However, the therapeutic value of this mechanism in celiac disease will depend on clinical evidence demonstrating an acceptable safety profile and meaningful effects on disease-related outcomes. The Phase 1b program is an early-stage evaluation, and additional studies would generally be required to establish the therapy’s efficacy, optimal dosing and potential role in clinical practice. ANB033 is also being developed for eosinophilic esophagitis, another inflammatory disease involving immune pathways, according to the company’s pipeline description.
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Phase II Combination Study Advances Clinical Program
First Tracks Biotherapeutics scheduled its investor call and live webcast for October 12, 2026, at 8:30 a.m. ET / 5:30 a.m. PT to discuss Cohort 1 results. The company stated that the data would be provided in a morning press release and presented during the webcast, with a replay expected to remain available for at least 30 days. The announcement comes as First Tracks advances a broader pipeline of antibody therapeutics targeting immune pathways involved in autoimmune and inflammatory conditions. In addition to ANB033 for celiac disease and eosinophilic esophagitis, the company is developing rosnilimab, a pathogenic T-cell depleter for rheumatoid arthritis, and ANB101, a BDCA2 modulator. The planned ANB033 update may help clarify the progress of the company’s celiac disease program, but the significance of the findings will depend on the reported clinical data, including measures of intestinal mucosal injury and treatment safety. No efficacy or safety conclusions can yet be drawn from the October 11 announcement alone.
Source:: First Tracks Biotherapeutics press release
