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;”