Omvoh: which tox species, and why?

“The toxicology package submitted by the applicant comprised studies in a single species (cynomolgus monkey) using the intended clinical routes of administration (intravenous and subcutaneous).”

“Similar binding kinetics were demonstrated for cynomolgus monkey IL-23 with a calculated value of 55 pM, however, the binding affinity for rabbit IL-23 was > 1000 fold lower and no binding to mouse or rat IL-23 was detectable.”

“Neutralization of IL-23 using a surrogate mouse antibody, LSN2479016, demonstrated efficacy in two murine models of inflammatory bowel disease.”

“The toxicology package submitted by the applicant comprised studies in a single species (cynomolgus monkey) using the intended clinical routes of administration (intravenous and subcutaneous).”

“For the assessment of male and female fertility, sexually mature monkeys were used in the 6-month repeat dose toxicity study (Report 20043324).”

“Conventional rodent carcinogenicity studies were not conducted for the evaluation of the carcinogenic potential of mirikizumab as rodents are not a pharmacologically relevant species.”

“As LY3074828 does not bind to rodent IL-23, a surrogate mouse antibody (LSN2479016) was developed to neutralize mouse IL-23 for use in preclinical disease models.”