Exdensur: how long were the pivotal tox studies?

“A GLP-compliant repeat dose toxicity study in cynomolgus monkeys receiving depemokimab 10mg/kg and 100 mg/kg once every 3 months for 26 weeks has been performed.”

“In the 26-week toxicology study conducted in monkeys, doses of 10 (low dose [LD]) and 100 (high dose [HD]) mg/kg were administered to adult male and female monkeys (4/sex/group) once every 13 weeks for a total of 2 doses.”

“Multiple dose toxicokinetics were determined in a 6 month repeat dose SC toxicity study in cynomolgus monkeys (3/sex/group) who received 2 doses of depemokimab (10 and 100 mg/kg bw) on Day 1 and during Week 14.”