Brexafemme: how long were the pivotal tox studies?

“Daily administration of oral ibrexafungerp for 26 weeks in rats, at the highest dose of 80 mg/kg/day (approximately 10 times the RHD based on AUC comparison), was associated with marked, but reversible, phospholipidosis and foamy histiocytes in alveolar tissue in the lung and labored breathing, marked irritation and metaplasia in gastric mucosa, and peripheral nerve degeneration accompanied by hind-limb paralysis.”

“Oral-dose toxicology studies with ibrexafungerp included 1-month and 13-week studies in rats and dogs.”

“Administration of SCY-078 citrate by once daily oral gavage for 13 weeks was well tolerated in dogs at dose levels of 15, 30, and 60 mg/kg/day.”