Forte Biosciences has reported that its topical live biotherapeutic, FB-401, failed to meet the primary goal of its Phase II clinical trial in atopic dermatitis patients.
FB-401 has three therapeutic strains of a commensal gram-negative bacteria, Roseomonas mucosa, that were specially chosen for their effect on vital parameters of inflammatory skin disease.
The company commenced the Phase II trial in September 2020.
Nearly 58% of subjects in the FB-401 arm versus 60% in the placebo arm met the primary goal of EASI-50. Forte noted that the drug failed to meet statistical significance on this endpoint.
EASI-50 is the proportion of subjects with a minimum of 50% improvement in atopic dermatitis disease severity as measured by EASI.
Furthermore, positive trends were noted in key secondary goals, including EASI-90.
Nearly 27.6% of participants in the active group met the EASI-90 goal versus 20.5% in the control group.
In the investigator’s global assessment (IGA) success, defined by two-point reduction and clear or almost clear, 38.2% receiving FB-401 attained success as against 29.5% in the placebo group.
Based on these data, the company has decided to discontinue the further development of FB-401.
Forte Biosciences CEO Paul Wagner said: “We are appreciative of the clinical trial sites and the patients for participating in this trial and we are grateful to our investors for taking the risk to support the advancement of a new therapeutic modality for atopic dermatitis.
“The top-line data is disappointing and we will continue to analyse the data; however, given this readout, we will not continue to advance FB-401.”
According to Forte’s preclinical and mechanism of action data, FB-401 was showed to improve atopic dermatitis disease parameters by inducing tissue repair, anti-inflammation and potential suppression of bacteria such as Staphylococcus aureus (S. aureus).