Forte Bio decimated as FB-401 fails to meet statistical significance

Shares in Forte Biosciences (Nasdaq: FBRX) plummeted 81.6% to $5.25 pre-market today, after it revealed late Thursday that top-line data from its Phase II 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).

Forte Bio gained rights to the compound along with its acquisition last year of US biopharma company Tocagen.

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).