Landos Biopharma, Inc. announced final results from the Phase 1 study of BT-11, a first-in-class, orally active, gut-restricted therapeutic for the treatment of ulcerative colitis (UC) and Crohn disease (CD). The randomized, double-blind, placebo-controlled trial conducted in 70 healthy subjects to assess the safety of BT-11 found that BT-11 was well-tolerated and showed no dose-limiting toxicities. Among the subjects, the overall adverse events (AEs) profile observed was consistent when compared to AEs in the placebo cohort and no differences were observed between groups. The study tested levels of BT-11 ranging from 7 mg/kg up to 100 mg/kg and did not reach a maximum tolerated dose. This randomized, double-blind, placebo-controlled Phase 1 trial evaluated the safety and tolerability of BT-11 in five cohorts of single ascending and three cohorts of multiple ascending dose studies in 70 healthy subjects. The study tested levels of BT-11 ranging from 7 mg/kg up to 100 mg/kg. Within the subject group of the study, BT-11 was well-tolerated and showed no safety concerns or dose-limiting toxicities. In addition, biomarker and immune screening results indicated that subjects in the single and multiple ascending dose studies had lower levels of fecal calprotectin, an inflammatory biomarker, compared to the placebo cohort. In addition, BT-11 did not induce systemic immuno suppression as measured by white blood cell counts relative to placebo in either study.