TORRANCE, Calif.--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, today announced the publication in Science Translational Medicine of the full results of the Phase 1/2a data for its lead product candidate, FB-401.
FB-401, a live biotherapeutic consisting of specifically selected strains of commensal Roseomonas mucosa, was studied in an open-label Phase 1/2a trial in atopic dermatitis (AD) patients and demonstrated excellent tolerability and significant improvement in disease activity in both adults and children.
In the pediatric cohort, 20 AD patients with mild, moderate and severe disease, ranging in age from 3 to 16 years of age, were treated topically with FB-401 for 16 weeks (twice weekly for 12 weeks and every other day for the final 4 weeks). 90% (18/20) of the pediatric patients reported at least a 50% improvement in the Eczema Activity and Severity Index (EASI-50) with 100% (9/9) of the moderate-to-severe patients achieving EASI-50. The mean improvement in the EASI score was 77% with improvements observed on all actively treated body sites. Pruritus (itch) also improved by an average 58%. The mechanism of action for FB-401 involves pathways that drive tissue repair and anti-inflammation.
“The publication of the clinical and mechanistic data in Science Translational Medicine highlights the significant potential of FB-401, particularly for pediatrics, who account for a significant fraction of AD patients and for whom safe and effective treatment options are limited” said Paul Wagner, Ph.D., Chief Executive Officer of Forte Biosciences. “We look forward to continuing to advance this important therapy and initiating our randomized placebo-controlled trial of FB-401 in AD patients 2 years of age and older.”
For additional information about the trial, see ClinicalTrials.gov using identifier NCT04504279.
About Forte
Forte Biosciences, Inc. is a clinical stage dermatology company developing a live biotherapeutic, FB-401, for the treatment of inflammatory skin diseases. FB-401 has completed Phase 1/2a testing in adult and pediatric (3 years of age and older) patients with atopic dermatitis. There is a significant unmet need for safe and effective therapies particularly for pediatric atopic dermatitis patients. Forte is preparing for the initiation of the randomized Phase 2 clinical trial for FB-401 in the third quarter of 2020.
Forward Looking Statements
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Source: Forte Biosciences, Inc.