Roseomonas mucosa (FB-401) / Forte Biosci, National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Skin Environmental and Microbial Crosstalk in AD Pathogenesis (ISAD-RAJKA 2025) - "Clinical research on targeted interventions using single bacterial strains is also advancing, including studies on ShA9, FB-401 (a consortium of three R. mucosa strains), and Nitrosomonas eutropha B244 (an ammonia-oxidizing bacterium). However, the mechanisms affect the microbiota are still under active investigation. Drawing on our research findings, we will provide a brief overview integrating the above aspects."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus

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. (PubMed, Dermatology) - "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."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study (clinicaltrials.gov) - P2; N=36; Terminated; Sponsor: Forte Biosciences, Inc.; N=25 ➔ 36; Trial completion date: Aug 2022 ➔ Sep 2021; Recruiting ➔ Terminated; Trial primary completion date: Aug 2022 ➔ Sep 2021; Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=154; Completed; Sponsor: Forte Biosciences, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical Trial of FB-401 For the Treatment of Atopic Dermatitis Fails to Meet Statistical Significance (Businesswire) - P2, N=25; NCT04936113; Sponsor: Forte Biosciences; "Forte Biosciences...announced that topline data from its Phase 2 clinical trial of FB-401 for the treatment of atopic dermatitis failed to meet statistical significance for the primary endpoint of EASI-50 (the proportion of patients with at least a 50% improvement in atopic dermatitis disease severity as measure by EASI)....Positive trends were observed in key secondary endpoints including EASI-90 with 27.6% of subjects in the active arm achieving the EASI-90 endpoint compared to 20.5% in the control arm (p=0.3075) and in IGA success (2 point reduction and clear or almost clear) with 38.2% of active subjects achieving success compared to 29.5% in the placebo arm (p=0.2599). The primary endpoint of EASI-50 was achieved by 58% of subjects on FB-401 compared to 60% of subjects on placebo (p=0.7567)."

P2 data • Atopic Dermatitis • Immunology

Forte Biosciences, Inc. to Review the Second Quarter 2021 Results and Expects to Announce Topline Data From Phase 2 Clinical Trial of FB-401 for the Treatment of Atopic Dermatitis on Sept. 7 (Businesswire) - "Forte Biosciences...will review the second quarter results and, based on the projected timing of database lock and completion of statistical programming and analysis, expects to announce topline data from its Phase 2 clinical trial of FB-401 for the treatment of atopic dermatitis on September 7, 2021."

P2 data • Atopic Dermatitis • Immunology

Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study (clinicaltrials.gov) - P2; N=25; Recruiting; Sponsor: Forte Biosciences, Inc.

Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Forte Biosciences, Inc. Announces First Quarter 2021 Results and Provides a General Business Update (Businesswire) - P=NA, N=154; "...our randomized clinical trial of FB-401 in atopic dermatitis patients 2 years of age and older, including adolescents and adults, completed enrollment. We expect to report the topline results from that trial in the third quarter of 2021."

Clinical data • Enrollment status • Atopic Dermatitis • Dermatology • Immunology

Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=154; Active, not recruiting; Sponsor: Forte Biosciences, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

"$FBRX Granted Fast Track Designation To FB-401 For The Treatment Of Atopic Dermatitis" (@BioStocks)

Fast track designation • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Forte Biosciences, Inc. Announces the FDA Has Granted Fast Track Designation to FB-401 for the Treatment of Atopic Dermatitis (Yahoo Finance) - "Forte Biosciences...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis."

Fast track designation • Atopic Dermatitis • Immunology

Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=124; Recruiting; Sponsor: Forte Biosciences, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Forte Biosciences, Inc. Announces First Patient Dosed in the Clinical Trial of FB-401 for the Treatment of Children and Adults With Atopic Dermatitis (Businesswire) - "Forte Biosciences...today announced that the first patient has been dosed in the clinical trial of FB-401 for the treatment of atopic dermatitis....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)."

Trial status • Atopic Dermatitis • Immunology

Forte Biosciences, Inc. Announces Full Publication of Phase 1/2 Data in Science Translational Medicine (Businesswire) - P1/2, N=124; NCT04504279; Sponsor: Forte Biosciences, Inc.; "FB-401...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.... 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."

P1/2 data • Atopic Dermatitis • Dermatology • Immunology