Ultomiris: which tox species, and why?

“the murine surrogate molecule BB5.1 was administered to mice due to lack of pharmacologic activity of ALXN1210 in mice.”

“Neither ALXN1210 nor eculizumab exhibit detectable pharmacological activity against any non‐human species tested, as was predicted by epitope mapping studies and sequence alignments of human and non‐human C5 molecules, and confirmed by in vitro binding and activity studies.”

“the murine surrogate molecule BB5.1 was administered to mice due to lack of pharmacologic activity of ALXN1210 in mice.”

“For the following studies in the toxicology package, the murine surrogate molecule BB5.1 was administered to mice due to lack of pharmacologic activity of ALXN1210 in mice.”

“Animal reproductive toxicology studies have not been conducted with ravulizumab, but were conducted in mice with a murine surrogate complement inhibitory antibody, BB5.1.”

“Long-term animal carcinogenicity studies of ravulizumab-cwvz have not been conducted.”

“A GLP‐ compliant 26‐week repeat‐dose toxicity study, and GLP‐compliant reproductive and developmental toxicology studies, were performed in mice using a surrogate murine anti‐ mouse C5 mAb (BB5.1).”