Tremfya: which tox species, and why?

“The applicant submitted one single dose and one pivotal 5-week (IV/SC)/24-week (SC) repeat dose toxicity studies in cynomolgus monkey”

“Guselkumab demonstrated comparable species binding to IL-23 from humans, non-human primates (including cynomolgus monkeys), and guinea pigs, but only partial or no binding to dog, mouse, or rat IL-23.”

“The influence of guselkumab administration on fertility was assessed in female and male Guinea Pigs that were dosed 50 or 100 mg/kg guselkumab subcutaneously twice a week.”