Forte Biosciences announces first patient dosing in atopic dermatitis trial

Forte Biosciences announced that the first patient has been dosed in the clinical trial of FB-401 for the treatment of atopic dermatitis. The multi-center, placebo controlled clinical trial of FB-401 is expected to enroll approximately 124 pediatric, adolescent and adult subjects aged 2 years of age and older with atopic dermatitis,AD. The primary endpoint of the trial is EASI-50, which is a measure of the proportion of patients that achieve at least a 50% improvement in the atopic dermatitis disease burden as measured by the Eczema Area and Severity Index, EASI. FB-401 is a topically applied live biotherapeutic consisting of specifically selected strains of commensal Roseomonas mucosa and has demonstrated excellent tolerability and significant improvement in atopic dermatitis disease activity in both adults and children in a Phase 1/2a trial which was recently published in Science Translational Medicine. "We are very excited to be initiating this clinical study," said Paul Wagner, Ph.D., Chief Executive Officer of Forte Biosciences. "FB-401 has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis. Children, in particular have limited treatment options and account for the majority of the approximately 17 million AD patients in the U.S. alone." For additional information about the trial, see ClinicalTrials.gov using identifier NCT04504279.