Xolremdi: which tox species, and why?

“Both rats and dogs were considered pharmacologically relevant species for conducting toxicology assessments of mavorixafor based on the observation of the desired pharmacology and similar metabolite profiles compared to humans.”

“Both rats and dogs were considered pharmacologically relevant species for conducting toxicology assessments of mavorixafor based on the observation of the desired pharmacology and similar metabolite profiles compared to humans.”

“The safety of mavorixafor (free base form) was evaluated in good laboratory practice-compliant, repeated dose toxicology studies in rats (28 days) and dogs (up to 39 weeks).”

“The safety of mavorixafor (free base form) was evaluated in good laboratory practice-compliant, repeated dose toxicology studies in rats (28 days) and dogs (up to 39 weeks).”

“No dedicated fertility and early embryonic development, definitive embryo-fetal development, or pre- and post-natal development toxicity studies were conducted with mavorixafor. The Applicant provided a weight-of-evidence assessment informing potential reproductive risks associated with mavorixafor treatment.”

“Postmarketing requirements for the conduct of rat and mouse carcinogenicity studies will be issued.”

“Intraperitoneal administration of a selective and competitive CXCR4 antagonist plerixafor or a CXCL12-neutraliser chalcone 4 increased the absolute numbers of total leukocytes including neutrophils, B and T cells both in the blood of mice carrying WT CXCR4 and in blood of Cxcr4+/1013 mice.”