Rystiggo: which tox species, and why?

“The repeat dose studies were primarily performed in cynomolgus monkey, as the NHP was found to be the only pharmacological relevant species.”

“Affinity (KDs) for rozanolixizumab for mouse and rat FcRn was much weaker (nanomolar range) and binding to rabbit FcRn was not observed at all.”

“The ability of a mouse surrogate (4470) of rozanolixizumab to increase clearance of IgG was evaluated in a mouse disease model of immune thrombocytopenia (ITP).”

“General toxicity studies of 4-, 13- and 26-weeks’ duration were conducted in cynomolgus monkey administered up to 150 mg/kg UCB7665 by SC injection every 3 days.”

“Given that only the nonhuman primates (NHP) was found to be a relevant species – an ePPND study was performed in cynomolgus monkeys. No stand-alone fertility and early embryonic development studies have been conducted with rozanolixizumab. Fertility endpoints were included in the pivotal 26 weeks repeat dose study.”

“Based on a weight of evidence assessment, conduct of carcinogenicity studies were deemed not necessary for UCB7665.”

“The ability of a mouse surrogate (4470) of rozanolixizumab to increase clearance of IgG was evaluated in a mouse disease model of immune thrombocytopenia (ITP).”