Taltz: which tox species, and why?

“Toxicity of ixekizumab was evaluated in vitro and in vivo in Cynomolgyus monkeys; studies were justified in Cynomolgus monkeys on the basis that other species did not show pharmacological sensitivity to ixekizumab whereas this was similar between humans and Cynomolgus monkeys.”

“The results demonstrate that ixekizumab binds human and cynomolgus monkey IL-17 with similar affinities in a concentration dependent manner. Ixekizumab also binds to rabbit IL-17, but the affinity is lower and heterogenous. However, ixekizumab shows no binding to both mouse and rat IL-17.”

“Two surrogate antibodies that cross react with murine IL-17 were used in nonclinical collagen-induced arthritis (CIA) and experimental autoimmune encephalomyelitis (EAE) models.”

“Toxicity of ixekizumab was evaluated in vitro and in vivo in Cynomolgyus monkeys; studies were justified in Cynomolgus monkeys on the basis that other species did not show pharmacological sensitivity to ixekizumab whereas this was similar between humans and Cynomolgus monkeys.”

“Fertility, embryofetal development and peri- and postnatal development studies have been conducted with ixekizumab in cynomlgus monkeys treated by subcutaneous injection with up to 50 mg/kg/week.”

“No genetic toxicity or carcinogenicity studies have been conducted with ixekizumab.”

“Two surrogate antibodies that cross react with murine IL-17 were used in nonclinical collagen-induced arthritis (CIA) and experimental autoimmune encephalomyelitis (EAE) models.”