Piasky: how long were the pivotal tox studies?

“A 6-Month Intermittent Subcutaneous or Intravenous Administration Toxicity Study of SKY59 (Crovalimab) in Mature Cynomolgus Monkeys Followed by a 6-Month Recovery Period (Study 1082669)”

“Crovalimab was administered SC at dose levels of 10, 40, and 100 mg/kg QW for 26 weeks after a single IV injection of 100 mg/kg on Day 1 of the study and was administered to an additional group IV at a dose level of 160 mg/kg.”

“Then, one pivotal with 2 different administration schemes (IV up to 4 weeks with 17-week recovery and SC up to 5 months with no recovery) was performed as same as the long-term term study in which both administration routes were used (26-week GLP study SC QW and IV Q2W with 26-week recovery).”