Orladeyo: which tox species, and why?

“General toxicity studies included chronic oral toxicity studies in rats and monkeys (treatment durations of up to 26 and 39 weeks, respectively).”

“monkey and rat plasma with mean EC50s of 5.4, 5.2, and 7.2 nM (Study BR-7353-005-REV-01), supporting the suitability of monkey and rat as the non-clinical species used for toxicology studies.”

“Cynomolgus monkeys (4/sex/dose) were dosed by oral gavage with 0, 1, 2.5, 7.5, and 20 mg/kg/day berotralstat for 39 weeks.”