Skyrizi: which tox species, and why?

“The cynomolgus monkey was the only relevant species due to insufficient cross-reactivity of risankizumab to IL-23 from rodents.”

“Binding of risankizumab to Cynomolgus monkey IL-23 was also high, with a dissociation constant (Kd) of less than 1 pM. Risankizumab bound to mouse IL-23 with a Kd of 15 nM.”

“The Cynomologus monkey was identified as the pharmacologically relevant species and used in toxicology studies.”

“The cynomolgus monkey was the only relevant species due to insufficient cross-reactivity of risankizumab to IL-23 from rodents.”

“The effects of risankizumab on embryo-foetal as well as on pre- and postnatal development were evaluated in an enhanced pre- and postnatal development (ePPND) toxicity study in cynomolgus monkeys.”

“Conventional rodent carcinogenicity studies were not conducted for the evaluation of the carcinogenic potential of risankizumab, as rodents are not a pharmacologically relevant species.”

“The Cynomologus monkey was identified as the pharmacologically relevant species and used in toxicology studies.”