Anzupgo: which tox species, and why?

“repeat-dose toxicity studies in mice (dermal; 3 months), rats (oral; up to 6 months), dogs (oral; up to 9 months), and minipigs (dermal; up to 9 months)”

“Comparison of human, mouse and rat T cells demonstrated a comparable inhibitory effect across all species, supporting the in vivo species selection.”

“No treatment-related changes were observed in a 9-month dermal toxicity study in minipigs treated with delgocitinib ointment.”

“repeat-dose toxicity studies in mice (dermal; 3 months), rats (oral; up to 6 months), dogs (oral; up to 9 months), and minipigs (dermal; up to 9 months)”

“Reproductive and developmental toxicology studies included fertility and early embryonic development studies in male and female rats, embryo-fetal development studies in rats and rabbits, and a pre- and postnatal development study in rats.”

“In the dermal carcinogenicity study in mice, delgocitinib ointment (1%, 3% and 5%) was administered once daily for 104 weeks. No drug-related neoplastic findings were noted at topical doses up to 5% delgocitinib ointment. In the 2-year oral carcinogenicity study in rats, increased incidence of benign thymoma was noted in females at 30 mg/kg/day”

“No treatment-related changes were observed in a 9-month dermal toxicity study in minipigs treated with delgocitinib ointment.”