First Tracks reports positive Phase 1b celiac data, plans late-stage trial in 2027
The company also disclosed a $200 million private placement and pro forma cash of $343 million, as it moves ANB033 toward registrational studies.
First Tracks Biotherapeutics reported financial results for the third quarter ended September 30, 2026, along with a business update dated November 3, 2026. The company said ANB033, a subcutaneously administered CD122 antagonist designed to inhibit signaling of both IL-15 and IL-2 on immune cells, demonstrated statistically significant protection against gluten-induced intestinal damage and symptoms and was well tolerated in the Phase 1b gluten-challenge cohort.1
In that Cohort 1 analysis, the least squares mean change from baseline in villus height-to-crypt depth ratio was -0.17 on ANB033 versus -0.66 on placebo, a placebo-adjusted delta of +0.49 (p=0.009), and the mean change in intraepithelial lymphocyte density was -1.20 on ANB033 versus +18.83 on placebo, a -20.03 placebo-adjusted delta (p<0.001).1 The company also said ANB033 prevented an increase in symptoms throughout the gluten challenge, with no safety signals observed.1
Enrollment has finished for Cohort 2, which is evaluating mucosal healing, and top-line data are anticipated in the first quarter of 2027.1 The company plans to engage regulators, including the FDA, which has already granted ANB033 Fast Track designation, and to initiate a late-stage clinical trial in celiac disease in 2027.1 A separate Phase 1b trial in eosinophilic esophagitis is enrolling, with top-line data anticipated in the third quarter of 2027,1 and the company plans to begin Phase 2 development of ANB033 in vitiligo and one additional indication in the first half of 2027.1
On rosnilimab, the company said it is currently assessing return-on-equity-maximizing strategic options for its development in rheumatoid arthritis and other indications.1 For ANB101, a Phase 1a healthy-volunteer trial is complete and the company is weighing next steps.
First Tracks reported cash, cash equivalents and investments of $155.6 million as of September 30, 2026, with pro forma cash of $343 million following a $200 million private placement completed in October 2026.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.