Xenleta: which tox species, and why?

“Lefamulin was evaluated in 4-week oral toxicology studies in rats and cynomolgus monkeys.”

“The major human lefamulin metabolite, BC-8041 (2R-hydroxy-lefamulin), is present in rat and monkey, the species used in the pivotal toxicology studies.”

“In a 13-week repeated dose toxicity study in monkeys, a formulation containing 6.67 mg/mL lefamulin dissolved in 10 mM citrate-buffered saline was tolerated for approximately 6 weeks”