Tavneos: which tox species, and why?

“The Sponsor conducted oral toxicology studies up to 26 weeks in rats, 13 weeks in hamsters, and 44 weeks in monkeys.”

“The hamster and monkey were pharmacologically relevant species and could assess both potential on-target and off-target toxicity. However, the rat was not a pharmacologically relevant and could only assess potential off-target toxicity.”

“In the 13-week toxicology study in hamster, CCX168 was administered at doses of 0 (vehicle), 10, 30, 100 and 1000 (500 mg/kg BID) mg/kg/day.”

“The Sponsor conducted oral toxicology studies up to 26 weeks in rats, 13 weeks in hamsters, and 44 weeks in monkeys.”

“Fertility and reproductive performance were unaffected in a fertility and early embryonic development study with male and female hamsters that received oral doses of CCX168 up to 1000 mg/kg/day. In embryofetal development studies with hamsters and rabbits, no fetal harm or malformations were observed with oral doses of CCX168 up 1000 and 200 mg/kg/day.”

“Two-year carcinogenicity studies in Sprague-Dawley rats and Syrian hamsters were conducted to assess the carcinogenic potential of avacopan.”

“Therefore, a human C5a receptor knock in (hC5aR KI) transgenic mouse strain was generated, where the murine C5aR gene was replaced by the human C5aR gene.”