Livdelzi: which tox species, and why?

“Repeat-dose po administration of seladelpar was evaluated at up to 13 weeks in CD-1 mice, up to 26 weeks in Sprague-Dawley rats, up to 4 weeks in dogs, and up to 52 weeks in cynomolgus monkeys.”

“The selection of multiple species for the non-clinical programme was justified by the sensitivity differences towards PPARs between species.”

“General toxicology studies with seladelpar (orally administered) were performed in mice, rats, dogs, and monkeys, with adverse effects noted in each species.”

“The nonclinical safety profile of seladelpar has been extensively explored in (1) single- and repeated-dose toxicology studies in rats (up to 6 months) and monkeys (up to 12 months)”

“Reproductive and developmental toxicology studies using oral administration of seladelpar included a fertility study in male and female rats, EFD studies in rats and rabbits, and a pre- and postnatal development study in rats.”

“(4) 2-year carcinogenicity studies in mice and rats”

“Seladelpar was shown to activate PPARα and PPARδ in C57Bl/6N wild-type mice and only PPARδ in the PPARα-knockout mice at the same exposure levels as in the 2-year carcinogenicity study.”