Forte Biosciences (NASDAQ:FBRX) dosed the first patient in its Phase 2 trial evaluating FB-401 for the treatment of atopic dermatitis.
FB-401 is a topical mixture comprised primarily of three strains of the commensal skin bacteria Roseomonas mucans. In a Phase 1/2a study, FB-401 demonstrated statistically significant improvements in atopic dermatitis disease activity.
The Phase 2 placebo-controlled trial will enroll some 124 atopic dermatitis patients. The study’s primary endpoint of the trial is eczema area and severity index (EASI)-50, which is a measure of the proportion of patients that achieve at least a 50% improvement in the atopic dermatitis disease burden.
“FB-401 has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis,” Paul Wagner, Ph.D., Forte’s CEO, said in a statement.
“Children in particular have limited treatment options and account for the majority of the approximately 17 million atopic dermatitis patients in the U.S. alone,” he added.
