Although bacteria are often associated with infection and disease, much of the bacteria that colonize the human body are essential for life. Until recently, few scientific studies focused on the benefits of commensal bacteria.

The NIH was the first to culture gram negative bacteria from the skin and has been a thought leader in understanding the bacterial composition of the skin. That work at NIH demonstrated:

  • Significant differences in the Gram-negative skin biome between AD patients and healthy volunteers, using genetic-based microbiome identification;
  • Substantial differences in the Gram-negative microbiome present on the skin of AD patients and healthy volunteers;
  • That the predominant species of skin commensal Gram-negative bacteria in healthy volunteers was Roseomonas mucosa; and
  • That over 50% of AD patients did not have any culturable Gram-negative flora, consistent with DNA-based analysis.

Rigorous preclinical testing established a causal connection between specific strains of R. mucosa and skin healing in AD. Subsequent screening based on key parameters of inflammatory skin disease resulted in the identification and selection of 3 unique therapeutic strains of R. mucosa that comprise FB-401. Forte initiated a Phase 2 clinical trial in September 2020.