Aduhelm: which tox species, and why?

“The toxicology of aducanumab was adequately assessed in general toxicity studies in monkey and Tg2576 mouse.”

“Neither rat nor monkey is a particularly relevant species for general toxicity because of the lack of aggregated amyloid in rodent or non-aged monkey.”

“In Tg2576 mouse, ch12F6A was administered for 13 weeks (0, 10, 70, or 500 mg/kg) or 6 months (0, 10, 40, or 250 mg/kg) weekly by intravenous injection; in each study, a separate group received aducanumab (500 or 250 mg/kg, respectively) according to the same regimen.”

“The toxicology of aducanumab was adequately assessed in general toxicity studies in monkey and Tg2576 mouse.”

“There were no adverse effects on fertility and early embryonic development, embryofetal development, or pre- and postnatal development in studies of aducanumab (0, 100, 300, and 1000 mg/kg/week IV) conducted in rat.”

“Carcinogenicity studies of aducanumab were not conducted because its target, aggregated Aβ, is not present in wild-type rodents.”

“In Tg2576 mouse, ch12F6A was administered for 13 weeks (0, 10, 70, or 500 mg/kg) or 6 months (0, 10, 40, or 250 mg/kg) weekly by intravenous injection; in each study, a separate group received aducanumab (500 or 250 mg/kg, respectively) according to the same regimen.”