Ebglyss: genotox, carcinogenicity and repro: done or skipped?

“Genetic toxicology studies are not applicable to monoclonal antibodies and were not conducted with lebrikizumab based on ICH S6 guidance.”

“There was no evidence of tissue proliferation (i.e., hyperplasia, pre-neoplastic lesions) or immunosuppression in the 9-month intravenous toxicology study in cynomolgus monkeys that received lebrikizumab doses up to 25 mg/kg/week. The overall data suggest that lebrikizumab has low carcinogenic potential.”

“No embryofetal toxicity or malformations, or test article related effects on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age. The NOAEL for maternal and developmental toxicity was 150/50 mg/kg/week (loading/maintenance doses).”

“Repeated administration of lebrikizumab up to 25 mg/kg/week IV or SC had no adverse effects on the evaluated parameters for cardiovascular, respiratory or behavioral effects.”