Saphnelo: which tox species, and why?

“All in vivo toxicity studies were conducted in cynomolgus monkeys which can be considered as a relevant species for evaluation of safety of anifrolumab.”

“Cynomolgus monkey was selected as the pharmacologically relevant toxicology model for nonclinical safety assessment based on binding and neutralisation activity of anifrolumab in monkey cells.”

“All in vivo toxicity studies were conducted in cynomolgus monkeys which can be considered as a relevant species for evaluation of safety of anifrolumab.”

“The nonclinical safety profile of anifrolumab was characterised in single IV dose toxicity studies in cynomolgus monkeys, in repeat dose toxicity studies in cynomolgus monkeys for up to 39-weeks of duration”

“A pre- and post-natal developmental toxicity study was conducted with anifrolumab in cynomolgus monkeys. Fertility or embryo-foetal developmental toxicity studies were not conducted.”

“Carcinogenicity studies with anifrolumab were not conducted. Anifrolumab does not bind to murine IFNAR1 and does not inhibit the biological activity of murine IFN-α.”

“Anti-murine IFNAR1 MAb 5A3 (anifrolumab surrogate) was effective in a murine model of scleroderma (Study# RIA546-0007) and an accelerated NZB/W F1 murine model of lupus”