Xcopri: which tox species, and why?

“The toxicology package included repeat-dose toxicity (up to 13 weeks in mice, 26 weeks in rats, and 52 weeks in monkeys, in vitro and in vivo genotoxicity,”

“Monkey had a similar metabolic profile as the human profile.”

“In the chronic (26-week) oral rat study, mortality was seen at the HD of 48 mg/kg/day and CNS clinical signs (decreased activity, uncoordinated gait) at doses ≥ 24 mg/kg/day.”