Livtencity: which tox species, and why?

“Pivotal repeat-dose toxicology evaluations for maribavir included good laboratory practice studies of up to 52 weeks duration in monkeys, 26 weeks duration in rats and 13 weeks duration in mice”

“Mice, rats and monkeys were chosen for single and repeat-dose toxicity studies because the main human metabolite of maribavir, VP 44469 was present in all of them and these species are common species for toxicity testing.”

“In the 52-week monkey study, 2 males at 400/300 mg/kg/day (two dose levels indicate dose adjustment during the study) and 1 male at 200 mg/kg/day were euthanized in extremis.”

“Pivotal repeat-dose toxicology evaluations for maribavir included good laboratory practice studies of up to 52 weeks duration in monkeys, 26 weeks duration in rats and 13 weeks duration in mice”

“No significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from GD 8 to 20, at exposures approximately half the human exposure at the RHD. In the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from GD 7 to post-natal day (PND) 21.”

“Two-year carcinogenicity studies were conducted in mice and rats administered oral doses up to 150 and 100 mg/kg/day, respectively.”

“In vivo pharmacodynamics effects on HCMV were analysed in different animal models (transplanted human tissue or surrogate animal viral strains) in comparison to ganciclovir a two other benzimidazole nucleosides.”