Leqembi: which tox species, and why?

“The pivotal (4- and 39-week) toxicity studies of lecanemab were conducted in cynomolgus monkey, the only pharmacologically relevant species.”

“Cynomolgus monkey IgG1 has a similar sequence to human IgG1 and cynomolgus monkeys were considered generally predictive of the pharmacokinetics of such antibodies in humans.”

“Given the production of anti-drug antibodies against lecanemab in rodents, microhemorrhage studies were conducted with the rodent surrogate, mAb158.”