Rezzayo: which tox species, and why?

“Pivotal repeated dose toxicity studies include studies in rats and cynomolgus monkeys with treatment durations, in both animal species, of 4, 13 and 26 weeks.”

“Cynomolgus monkeys were chosen as the nonrodent toxicology species due to similar in vitro metabolic stability and protein binding characteristics to humans and because monkeys have been shown to be predictive for echinocandin-induced toxicity in humans.”

“In the 26-week study, rezafungin was administered once weekly at 0, 10, 25, or 45 mg/kg.”

“Pivotal repeated dose toxicity studies include studies in rats and cynomolgus monkeys with treatment durations, in both animal species, of 4, 13 and 26 weeks.”

“Reproductive toxicity studies comprised studies on fertility and early embryonic development (Sprague Dawley rats), embryo-fetal development (Sprague Dawley rats, New Zealand White rabbits) and pre and postnatal development (Sprague Dawley rats).”

“No carcinogenicity studies have been conducted. Considering the proposed therapeutic indication and the proposed duration of treatment, this was considered a satisfactory approach.”

“Cynomolgus monkeys were chosen as the nonrodent toxicology species due to similar in vitro metabolic stability and protein binding characteristics to humans and because monkeys have been shown to be predictive for echinocandin-induced toxicity in humans.”