Skyclarys: which tox species, and why?

“GLP-compliant general oral (gavage) toxicity studies of omaveloxolone were conducted in Sprague Dawley rat and cynomolgus monkey, with durations up to 26 and 39 weeks, respectively.”

“Monkeys were chosen as the non-rodent non-clinical species in the omaveloxolone testing programme as dogs have previously been shown to develop species-specific gastrointestinal toxicity following repeated dosing with the chemically related substance, bardoxolone methyl.”

“Male and female cynomolgus monkeys (9-10/sex/group) were administered doses of 0 (sesame oil), 10, 30, or 100 mg/kg RTA 408 by daily oral gavage for 39 weeks with 4 weeks recovery;”

“GLP-compliant general oral (gavage) toxicity studies of omaveloxolone were conducted in Sprague Dawley rat and cynomolgus monkey, with durations up to 26 and 39 weeks, respectively.”

“Male and female fertility were investigated in rats, including early embryonic development, however, no TK analysis was performed. Embryofetal developmental (EFD) toxicity in rats and rabbits were conducted, including TK analysis in both species. PPND toxicity was investigated in rats”

“Carcinogenicity studies (26-week study in Tg.rasH2 mice and 2-year study in SD rats) are to be conducted as post-marketing requirements.”

“GLP-compliant general oral (gavage) toxicity studies of omaveloxolone were conducted in Sprague Dawley rat and cynomolgus monkey, with durations up to 26 and 39 weeks, respectively.”