Ponvory: which tox species, and why?

“The pivotal nonclinical studies were conducted in CD-1 mouse, Wistar rat, beagle dog, and New Zealand White rabbit.”

“In in vitro PD studies ACT-128800 was found to have a 5-fold reduced potency on rat S1P3 receptor as compared to the human counterpart. Nevertheless, the rat is considered a relevant species for the evaluation of the safety of ACT-128800.”

“In rat, oral administration of ponesimod (0, 3, 10, or 30 mg/kg/day in males and 0, 10, 30, or 100 mg/kg/day in females) did not result in an increase in tumors.”