A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) with Mild to Moderate Atopic Dermatitis

Background: Atopic dermatitis is a common chronic, relapsing and remitting inflammatory skin disorder associated with cutaneous dysbiosis. Current treatment options often fail to adequately control the disease and have unfavorable safety profiles. There is a need for new options that address these treatment shortcomings. Objective: To evaluate the efficacy, safety, and tolerability of FB-401, a live therapeutic product of 3 strains of Roseomonas mucosa, compared to matching placebo applied topically 3 times per week to participants ages & GE; 2 years of age with mild to moderate atopic dermatitis. Methods: A randomized, double-blind, placebo-controlled, parallel-group study. The primary outcome was the proportion of participants with 50% improvement in Eczema Area and Severity Index score from baseline at week 16. 154 subjects aged 2 or older with a clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria with mild or moderate severity were randomized 1:1 via Interactive Web Response System to FB-401 or placebo. Results: The proportion of subjects who achieved the primary outcome was similar between both treatment groups, with no significant treatment group differences observed at any post-baseline visit. The number of treatment emergent adverse events and the number of subjects with at least one was similar across treatment groups. One serious adverse event not related to treatment was reported. No treatment emergent adverse events led to treatment discontinuation or study discontinuation. Conclusions: FB-401 showed an acceptable safety profile, but failed to prove superior to placebo in treating children and adults with mild to moderate atopic dermatitis.