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

“Ibrexafungerp was negative for genotoxicity in both nonclinical in vitro assays (Ames assays and a chromosome aberration assay in mammalian cells) and in vivo studies (micronucleus study in rat bone marrow cells).”

“Carcinogenicity studies were not performed for ibrexafungerp due to the limited duration of its intended use for the treatment of VVC.”

“In pregnant rabbits, oral ibrexafungerp administered during organogenesis was associated with fetal malformations including absent forelimb(s), absent hindpaw, absent ear pinna, and thoracogastroschisis at dose exposures greater or equal to approximately 5 times the human exposure at the RHD.”

“Results from an in vitro hERG assay indicated that the ibrexafungerp IC50 for hERG inhibition was 1.4-fold higher than the plasma Cmax value associated with the recommended clinical dose of 600 mg/day ibrexafungerp in fed patients.”