Siliq: how long were the pivotal tox studies?

“Cynomolgus monkeys dosed with 0, 10, 25 or 90 mg/kg/dose SC brodalumab weekly for six months were observed with mild skin changes and histopathology (MD and HD), increased neutrophil counts (HD) and decreased albumin/globulin ratios (MD and HD).”

“In the pivotal repeat dose cynomolgus monkey toxicity study, animals dosed with 0, 10, 25 or 90 mg/kg/dose SC brodalumab weekly for six months were observed with mild skin changes and histopathology (MD and HD)”

“The NOAEL for this study was determined to be 350 mg/kg/dose for both SC and IV routes of administration.”