Ebglyss: which tox species, and why?

“Thus, cynomolgus monkeys were selected as a single pharmacologically relevant species for use in nonclinical studies with lebrikizumab.”

“Lebrikizumab binds with pM affinity to IL-13 of human and cynomolgus monkey, but not IL-13 of mouse or rat.”

“No surrogates were developed and used in lebrikizumab nonclinical studies.”

“GLP-compliant repeat-dose studies of 6 weeks, 13 weeks and 9 months in duration were conducted in cynomolgus monkeys to evaluate the toxicity and TK of lebrikizumab.”

“Toxicology program consisted of single and repeat-dose toxicity studies, fertility and embryofetal (EFD) development and pre- and postnatal development (PPND) studies in cynomolgus monkeys”

“Carcinogenicity risk assessment was done by weight of evidence approach and no studies were conducted.”

“No surrogates were developed and used in lebrikizumab nonclinical studies.”