Adbry: which tox species, and why?

“Therefore, cynomolgus monkey was selected as a single pharmacologically relevant species for use in nonclinical studies with tralokinumab.”

“The IL-13 amino acid sequence homology between human and cynomolgus monkey is 95%, whereas that between human and rodent is 55% for mouse and 62% for rat. Tralokinumab did not cross-react with mouse IL-13.”

“Therefore, cynomolgus monkey was selected as a single pharmacologically relevant species for use in nonclinical studies with tralokinumab.”

“The toxicity studies have been performed in line with the requirements of ICH S6 (R1) using cynomolgus monkeys as the single species in which there is relevant pharmacological activity.”

“reproductive and developmental toxicity studies in cynomolgus monkeys, including two fertility, one pilot embryofetal development, one prenatal and postnatal development study, and an enhanced prenatal and postnatal development (ePPND) study”

“No carcinogenicity studies have been performed and considering the lack of activity against IL-13 of rodent origin, traditional rodent studies are not possible.”

“Therefore, cynomolgus monkey was selected as a single pharmacologically relevant species for use in nonclinical studies with tralokinumab.”