Alhemo: which tox species, and why?

“The rabbit was selected as efficacy species, the Cynomolgus monkey was selected as the nonrodent safety species and both species were used in pharmacokinetic/pharmacodynamic (PK/PD) assessment.”

“Characterisation of concizumab binding to TFPI showed high affinity, sub-nanomolar binding to rabbit, NHP and human TFPI with similar binding constants (KD of 0.22 nM, 0.06 nM and 0.04 nM for rabbit, Cynomolgus monkey and human, respectively).”

“Toxicity studies of up to 52-week duration have been conducted in Cynomolgus monkeys with a normal coagulation system (non-haemophilic).”