Ebanga: which tox species, and why?

“The ansuvimab-zykl nonclinical safety studies included a good laboratory practice (GLP) 4­ week, intravenous, repeat-dose toxicology study in rhesus monkeys”

“The activity of ansuvimab-zykl was evaluated in three in vivo proof-of-concept studies in which rhesus monkeys were challenged with uniformly lethal doses of Kikwit 8U EBOV (1000 pfu).”

“No adverse ansuvimab-zykl-related findings were observed in the GLP 4-week toxicology study in rhesus monkeys up to the highest dose tested”

“The ansuvimab-zykl nonclinical safety studies included a good laboratory practice (GLP) 4­ week, intravenous, repeat-dose toxicology study in rhesus monkeys”

“Dedicated reproductive toxicology studies have not been conducted with ansuvimab-zykl. In accordance with ICH S6(R1), reproductive toxicology studies are generally not required for biologics to exogenous targets.”

“In accordance with ICH S1A and ICH S6(R1), carcinogenicity studies are not required as ansuvimab-zykl will be administered as a single intravenous (IV) infusion.”

“The ansuvimab-zykl nonclinical safety studies included a good laboratory practice (GLP) 4­ week, intravenous, repeat-dose toxicology study in rhesus monkeys”