“A 26-week toxicity study was conducted in cynomolgus monkeys intravenously administered sutimlimab at 60 and 180 mg/kg/week.”
✓ VerifiedFDA pharmacology/toxicology review, p. 6Source ↗
Pivotal GLP studies
Cynomolgus monkey 5-week (up to 100 mg/kg/week) and 26-week (up to 180 mg/kg/week) IV studies with 8-week recovery
“Sutimlimab has been evaluated in repeat-dose studies in cynomolgus monkey for 5 (up to 100 mg/kg/week) and 26 weeks (up to 180 mg/kg/week) with 8 weeks of recovery.”
“The intravenous route of administration was utilized in the repeated toxicology studies and the enhanced pre and postnatal study to match the intended clinical administration route.”