Bimzelx: which tox species, and why?

“The only relevant species for nonclinical testing is the nonhuman primate.”

“The non-clinical evaluation has been conducted in the Cynomolgus monkey only since bimekizumab has no or very low affinity for mouse IL-17A, IL-17F or IL-17AF.”

“Bimekizumab is not pharmacologically active in rodents and no anti-rodent IL-17 A/F surrogate is available.”

“Cynomolgus monkeys were used in all studies as they were considered to be the only relevant non-clinical species by the applicant.”

“The effects on male and female fertility were assessed by examination of reproductive organs, menstrual cycle lengths, or sperm analysis in the 26-week repeat-dose toxicity study in monkeys. In a pre- and postnatal developmental study, bimekizumab was administered to pregnant cynomolgus monkeys”

“Bimekizumab is not pharmacologically active in rodents and no anti-rodent IL-17 A/F surrogate is available. Thus, conventional rodent carcinogenicity studies were not conducted for evaluation of the carcinogenic potential of bimekizumab.”

“Bimekizumab is not pharmacologically active in rodents and no anti-rodent IL-17 A/F surrogate is available.”