Gomekli: which tox species, and why?

“Exploratory studies were conducted in mice, rats, dogs, and monkeys, while definitive toxicity studies were conducted in rats and dogs.”

“The rat and dog were selected as the general toxicology species based on mirdametinib’s PK and metabolism properties compared across species.”

“Mirdametinib was administrated for 13 weeks at dose of 0.1, 0.3 and 1 mg/kg/day (same doses used in the 4-weeks study).”

“Pivotal studies were performed in rats and dogs up to 3 months.”

“Preliminary embryo-foetal development (pEFD) toxicity studies were conducted in rats and rabbits. No definitive EFD studies were conducted. A fertility study was conducted in male and female rats.”

“A 26-week carcinogenicity study in mice was performed after a dose range study and a 2-year carcinogenicity study in rats is currently ongoing (started in August 2024).”

“Mirdametinib was administrated for 13 weeks at dose of 0.1, 0.3 and 1 mg/kg/day (same doses used in the 4-weeks study).”