Myqorzo: which tox species, and why?

“Repeat oral dose toxicology studies up to 26 weeks in rats and 39 weeks in dogs were conducted to support the chronic oral administration of aficamten intended for clinical use.”

“Both species are considered pharmacologically relevant given the high conservation of the cardiac myosin motor between species and based on in vitro and single-dose in vivo pharmacology studies.”

“Study Number/Title: Nonclin-0054/A 26-Week Study of CK-3773274 by Oral Gavage in Rats With a 2-Month Recovery Period”

“Repeat oral dose toxicology studies up to 26 weeks in rats and 39 weeks in dogs were conducted to support the chronic oral administration of aficamten intended for clinical use.”

“GLP-compliant reproductive toxicology studies including a fertility and early embryonic development study in rats, embryofetal development studies in rats and rabbits, and a pre- and post-natal development study in rats were conducted with aficamten.”

“The carcinogenic potential of aficamten was assessed in a 26-week study in transgenic rasH2 mice and a 2-year study in Sprague Dawley rats.”

“Both species are considered pharmacologically relevant given the high conservation of the cardiac myosin motor between species and based on in vitro and single-dose in vivo pharmacology studies.”