Ekterly: which tox species, and why?

“the Applicant characterized the toxicity profile of sebetralstat with general toxicity studies in dogs (up to 4 weeks), and rats and monkeys (4 weeks, 13 weeks, and long-term dosing at durations up to 6 months).”

“Pharmacology studies sufficiently justified the choice of species for toxicology investigations. The monkey, mouse and rat turned out to be the most relevant species (IC50 of 5.07 nM, 13.9 nM and 69.8 nM respectively).”

“In the 26-week study, daily oral gavage administration of 30, 100, or 300 mg/kg/day was clinically well tolerated, with no sebetralstat-related deaths.”