Takhzyro: which tox species, and why?

“Due to high anti-drug antibody (ADA) response in rats that reduced drug exposure, and combined with the apparent similarity in toxicity profile in rats and cynomolgus monkey, the cynomolgus monkey was selected as the single species for the pivotal 6-month toxicity study.”

“DX-2930 inhibits human, rat, and cynomolgus monkey pKal activity with comparable potencies (Table 2). Rats and cynomolgus monkeys are pharmacologically relevant species.”

“Rat and cynomolgus monkey were used as toxicology species based on in vitro pharmacology potency studies which indicated that pKal inhibition in rat and monkey was similar to human pKal inhibition.”