Hympavzi: how long were the pivotal tox studies?

“the toxicity and toxicokinetics of marstacimab were examined in male and female Crl:WI(Han) rats (n=15 per sex in vehicle and dosing groups, and n=3 (vehicle) and 4 (test-article) per sex in test-article TK satellite groups) via intravenous injections of 0, 60, 180, or 1000 mg/kg/week for 26 weeks.”

“Wistar Han rats and Cynomolgus monkeys in GLP-compliant repeat-dose studies of up to 3 months (monkeys) or 6 months (rats) in duration.”

“Intravenous administration of marstacimab at doses ranging from 30 to 500 mg/kg/week and SC administration of 90 mg/kg/week to monkeys had no effect on respiratory, neurological, or cardiovascular parameters.”