Spevigo: which tox species, and why?

“Spesolimab does not bind to IL36R in common nonclinical species. Therefore, BI 674304, a surrogate monoclonal antibody that specifically binds to mouse IL36R was developed to assess the pharmacology and toxicology of IL36R inactivation in mice.”

“spesolimab did not bind to IL36R from the mouse, mini pig, rhesus money, marmoset, rat, or hamster, and had very low affinity to IL36R from cynomolgus monkey.”

“BI 674304 was evaluated in a battery of nonclinical studies that included evaluation of PK, immunotoxicity, repeat-dose toxicity, and reproductive and developmental toxicology.”

“BI 674304 was evaluated in a pivotal 26-week repeat-dose general toxicity study in CD-1 mice.”

“A full Developmental and reproductive toxicology (DART) programme was performed with BI 674304.”

“Carcinogenicity was assessed based on data from chronic dosing of BI 674304 in mice, scientific literature on the potential role of IL36R in tumor promotion, and clinical data from spesolimab clinical trials.”

“BI 674304 was evaluated in a battery of nonclinical studies that included evaluation of PK, immunotoxicity, repeat-dose toxicity, and reproductive and developmental toxicology.”