Raxibacumab: which tox species, and why?

“Drug safety assessed in human volunteers and in a battery of nonclinical studies in healthy rabbits and non-human primates showed no evidence of toxicity at the maximum proposed, single therapeutic dose of intravenous raxibacumab to be administered to human adults of 40 mg/kg.”

“several drug efficacy studies of raxibacumab with and without antibiotic in inhalation anthrax animal models (NZW rabbit and cynomolgus macaque)”

“Healthy cynomolgus macaques administered 3 intravenous doses or 3 subcutaneous doses of 40 mg/kg raxibacumab once every 12 days”

“Drug safety assessed in human volunteers and in a battery of nonclinical studies in healthy rabbits and non-human primates showed no evidence of toxicity at the maximum proposed, single therapeutic dose of intravenous raxibacumab to be administered to human adults of 40 mg/kg.”

“A single embryonic-fetal development study was conducted in pregnant, healthy New Zealand White rabbits administered two intravenous doses of raxibacumab up to 120 mg/kg (three times the human dose on a mg/kg basis) on gestation days 7 and 14.”

“Carcinogenicity, genotoxicity, and fertility studies have not been conducted with raxibacumab.”

“Healthy cynomolgus macaques administered 3 intravenous doses or 3 subcutaneous doses of 40 mg/kg raxibacumab once every 12 days, or a single intramuscular dose (40 mg/kg) of raxibacumab, showed no adverse effects, including no effects up to 120 days post-dosing.”