Simponi: which tox species, and why?

“An overview of the repeat-dose toxicity studies with golimumab in cynomolgus monkeys as well as the supportive study with the murine analogous molecule cV1q is given in Table 1.”

“The cynomolgus monkey was chosen as the most relevant non-clinical species, since golimumab showed little or no neutralization of dog, rabbit, mouse or rat TNFα.”

“Supportive toxicology studies were conducted in mice using the analogous anti-mouse TNFα monoclonal antibody, cV1q, to evaluate the effects of anti-TNFα treatment on reproductive development and chronic toxicity.”