“Pivotal nonclinical studies were conducted in CD-1 mice and Cynomolgus monkeys; both were identified as relevant species in a series of pharmacology studies.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Why that species
Similar binding affinity to human, monkey and mouse IL-5 (KD 24, 20 and 31 pM)
“Reslizumab binds with similar affinity to human, monkey, and mouse IL-5 (KD = 24, 20, and 31 pM; respectively, as determined by BIAcore biosensor assays).”
✓ VerifiedFDA pharmacology/toxicology review, p. 30Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in mice, rabbits and cynomolgus monkeys
“The nonclinical program for reslizumab included studies conducted in mice, rabbits, and monkeys, which were all considered pharmacologically relevant species based on data from in vivo eosinophilia models in sensitized animals”
✓ VerifiedFDA pharmacology/toxicology review, p. 30Source ↗