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FB-401

Forte Biosciences is developing a new approach to treating inflammatory skin disease using a topical live biotherapeutic, FB-401. FB-401, consists of three therapeutic strains of a commensal gram-negative bacteria, Roseomonas mucosa that were specifically selected for their impact on key parameters of inflammatory skin disease. Forte has extensive preclinical and mechanism of action data demonstrating that FB-401 improves atopic dermatitis disease parameters by driving tissue repair and anti-inflammation as well as suppressing potentially harmful bacteria like S. aureus.

To date, a Phase 1/2a study has completed, including both adults and pediatric patients, demonstrating significant reduction in atopic dermatitis disease and pruritus, as well as control of S. aureus while tapering/eliminating steroid use. Forte initiated a Phase 2 clinical trial in September 2020.

Expanded access, also called “compassionate use”, enables some patients with an immediately life-threatening condition or serious disease to gain access to an investigational new drug for treatment outside of clinical trials when no alternative therapy options are available. Currently, Forte does not offer an expanded access program. Forte may revise this policy at any time.