The Food and Drug Administration (FDA) has granted Fast Track designation to FB-401 (Forte Biosciences) for the treatment of atopic dermatitis.

FB-401 is a topically applied live biotherapeutic that consists of 3 therapeutic strains of commensal Roseomonas mucosa. The designation was based on data from a phase 1/2a trial that showed the investigational treatment was associated with significant improvement in atopic dermatitis disease activity, as measured by the Eczema Area and Severity Index (EASI).

Results from the study showed that in the pediatric cohort (ages 3 to 16 years), EASI-50 (50% improvement in atopic dermatitis disease burden) was achieved in 90% of patients overall and in 100% of patients with moderate to severe disease. Additionally, treatment with FB-401 was associated with improvement in pruritus and was shown to contribute to tissue repair and exhibit anti-inflammatory properties.

The Company is currently recruiting participants for a phase 2 trial evaluating FB-401 in patients aged 2 years and older with mild to moderate atopic dermatitis. The primary end point of the trial is the proportion of patients achieving EASI-50 at week 16.

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“We are very appreciative of the decision by the FDA to grant FB-401 Fast Track designation,” said Paul Wagner, PhD, President and CEO of Forte Biosciences. “We look forward to working closely with the FDA as we accelerate the advancement of FB-401, which has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis.”

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Forte Biosciences, Inc. announces the FDA has granted Fast Track designation to FB-401 for the treatment of atopic dermatitis. [press release]. Torrance, CA: Forte Biosciences, Inc; October 26, 2020.