Kisunla: which tox species, and why?

“toxicity studies were conducted in cynomolgus monkey (6-week IV donanemab) to assess for any off-target toxicity, and in the PDAPP transgenic mouse model (6-week and 6-month SC mE8c, a murine surrogate) to assess for relevant on-target effects”

“Donanemab is not pharmacologically active in normal rodent or nonrodent; therefore, toxicity studies were conducted in cynomolgus monkey (6-week IV donanemab) to assess for any off-target toxicity”

“These studies used mE8c, the murine analog of donanemab, to avoid immunogenicity that would be expected with donanemab, a humanized antibody, in mouse.”