FB-401 is a topically applied live biotherapeutic consisting of specifically selected strains of commensal Roseomonas mucosa.

The first patient has been dosed in Forte Biosciences, Inc.’s clinical trial of FB-401 for the treatment of atopic dermatitis (AD).

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 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. It 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.

In the previously completed Phase 1/2a trial, the pediatric cohort enrolled AD patients with mild, moderate and severe disease, ranging in age from 3 to 16 years. Those patients were treated topically with FB-401 for 16 weeks (twice weekly for 12 weeks and every other day for the final 4 weeks). EASI-50 was achieved by 90% of the pediatric patients and 100% of the subset of moderate-to-severe pediatric patients. The mean improvement in the EASI score was 77%, with improvements observed on all actively treated body regions. The activity was durable through the follow-up period of up to 8 months after the end of treatment. Pruritus (itch) also improved by an average of 4 points (mean improvement of 58%). FB-401 has been shown to drive tissue repair and anti-inflammation while controlling potentially harmful bacteria like Staphylococcus aureus.

“We are very excited to be initiating this clinical study,” says Paul Wagner, Ph.D., Chief Executive Officer of Forte Biosciences, in a news release. “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.