Sotyktu: genotox, carcinogenicity and repro: done or skipped?

“Deucravacitinib and its two major metabolites, BMT-158170 and BMT-153261, tested negative in a battery of genotoxicity studies, i.e., Ames tests (deucravacitinib and metabolites), an in vitro mammalian chromosome aberration test (deucravacitinib), in vitro micronucleus tests (metabolites), and an in vivo mammalian (rat) erythrocyte micronucleus test.”

“Deucravacitinib did not cause increases of tumor incidences in a 6-month oral carcinogenicity study in transgenic rasH2 mice and a 2-year oral carcinogenicity study in rats.”

“In animal reproduction studies, no effects on embryo-fetal development were observed with oral administration of deucravacitinib to rats and rabbits during organogenesis at doses that were at least 72 times the maximum recommended human dose (MRHD) of 6 mg once daily (see Data ) .”

“Deucravacitinib is not expected to inhibit hERG potassium channel current at clinically relevant concentrations. During the neurobehavioral and respiratory safety assessments, oral administration of deucravacitinib in rats at doses up to 75 mg/kg/day and in monkeys at doses up to 5 mg/kg/day did not cause neurological or respiratory effects.”