Zeposia: which tox species, and why?

“The main repeated dose toxicity studies have been conducted in Sprague Dawley rats and Cynomolgus monkeys with daily oral administration of ozanimod for up to 26 and 39 weeks, respectively.”

“Ozanimod was pharmacologically active in the nonclinical species (rat, monkey, rabbit, mouse) used to conduct the pivotal toxicology studies.”

“The main repeated dose toxicity studies have been conducted in Sprague Dawley rats and Cynomolgus monkeys with daily oral administration of ozanimod for up to 26 and 39 weeks, respectively.”

“The main repeated dose toxicity studies have been conducted in Sprague Dawley rats and Cynomolgus monkeys with daily oral administration of ozanimod for up to 26 and 39 weeks, respectively.”

“Studies on embryo-foetal development were conducted in rats and rabbits, while all the others were conducted in rats only.”

“Oral administration of ozanimod (0, 8, 25, or 80 mg/kg/day) to Tg.rasH2 mice for 26-weeks resulted in an increase in hemangioma and hemangiosarcoma (combined) in males and females at the mid and high doses tested. Oral administration of ozanimod (0, 0.2, 0.7, or 2 mg/kg/day) to rats for 2 years resulted in no increase in tumors.”

“Ozanimod was pharmacologically active in the nonclinical species (rat, monkey, rabbit, mouse) used to conduct the pivotal toxicology studies.”