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.”

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

“Reproductive and developmental toxicology studies were not conducted for lecanemab because of the age of the intended patient population.”

“Carcinogenicity studies were not conducted because of the lack of pharmacological activity in rodent species (mouse, rat), making standard carcinogenicity studies infeasible.”

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