Evenity: which tox species, and why?

“The Sprague Dawley rat and cynomolgus monkey were selected as the main rodent and non-rodent toxicology species as romosozumab binds to human, rat, and cynomolgus monkey sclerostin with similar affinity and is pharmacologically active in these species.”

“The Sprague Dawley rat and cynomolgus monkey were selected as the main rodent and non-rodent toxicology species as romosozumab binds to human, rat, and cynomolgus monkey sclerostin with similar affinity and is pharmacologically active in these species.”

“In some studies, rodent versions of the humanized antibody AMG785 (rat 13c7 (r13c7) and mouse 13c7 (m13c7)) were used because AMG785 causes anti-drug antibody (ADA) formation in those species.”

“Romosozumab has been evaluated in repeat-dose toxicity studies in rats (up to 26 weeks with 14 weeks recovery) and in monkeys (up to 26 weeks with 14 weeks recovery).”

“A full reproductive and developmental toxicity package has been performed in rats, including preliminary and definitive embryo-fetal development (EFD) studies, a combined fertility and EFD study, and a pre-and post”

“For romosozumab, a carcinogenicity study was conducted in Sprague Dawley rats. The rats were dosed for up to 98 weeks with 0, 3, 10, 50 mg/kg/week of romosozumab, equivalent to 1-19x human exposure.”

“In some studies, rodent versions of the humanized antibody AMG785 (rat 13c7 (r13c7) and mouse 13c7 (m13c7)) were used because AMG785 causes anti-drug antibody (ADA) formation in those species.”