Ogsiveo: which tox species, and why?

“The toxicity of nirogacestat was assessed in GLP‐compliant 3‐month repeated‐dose toxicity studies in rats and dogs.”

“The rat and dog were selected as the toxicology species based on nirogacestat PK and metabolism properties compared across species.”

“Rats received up to 25 mg/kg (50 mg/kg/day) oral nirogacestat, twice per day, for 3 months, resulting in mean exposure levels (AUC) up to 3.4 times the AUC of 6740 ng.h/mL in patients with desmoid tumors at the 150 mg BID dose.”

“The toxicity of nirogacestat was assessed in GLP‐compliant 3‐month repeated‐dose toxicity studies in rats and dogs.”

“The developmental and reproductive toxicology assessment of nirogacestat consisted of two separate fertility studies in male and female rats and a preliminary embryo-foetal toxicity study in pregnant rats.”

“The carcinogenicity of nirogacestat was assessed in a 6‐month repeat dose study in transgenic rasH2 mice (20174162).”