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

“Rezafungin was negative in a standard battery of assays, including an in vitro bacterial reverse mutation assay, an in vitro mammalian clastogenicity assay, and an in vivo rat bone marrow micronucleus assay.”

“No carcinogenicity studies have been conducted. Considering the proposed therapeutic indication and the proposed duration of treatment, this was considered a satisfactory approach.”

“Rezafungin did not affect mating or fertility in male and female rats following IV administration once every 3 days at doses up to 45 mg/kg (6 times the clinical exposure, based on AUC determined in a separate rat study). Decreased sperm motility was noted at ≥30 mg/kg and most males at 45 mg/kg showed mild/moderate hypospermia and had no detectable motile sperm.”

“Administration of a 20 minute IV infusion of rezafungin to telemetered male cynomolgus monkeys (NC-059), did not cause changes in body temperature, blood pressure, ECG and respiratory parameters at doses up to 10 mg/kg,”