Nulibry: which tox species, and why?

“Repeat-dose toxicity studies in juvenile rats for 13 and 26 weeks and in juvenile dogs for 39 weeks (Table 15).”

“The MoCo-synthesis is considered highly conserved between species, and cPMP is considered identical between species. Thus, rat and dog are considered relevant species for toxicity studies.”

“In the 39-week toxicity study in juvenile dogs in which fosdenopterin HBr (coded ALXN1101) was administered at 1, 3, 5, and 10 mg/kg/day once daily, no adverse effects were observed.”