Xacduro: genotox, carcinogenicity and repro: done or skipped?

“Durlobactam did not induce statistically significant increases in micronucleated PCEs at any test article dose up to 2000 mg/kg.”

“At doses up to 3 times the maximum recommended dose based on AUC comparisons, there were no toxicologically significant drug-related effects of durlobactam in pups born to rats dosed for 2 weeks prior to pairing, during pairing, and up to gestation Day 17.”

“There were no safety signals observed in safety pharmacology studies. Secondary pharmacology data did not reveal any potent activity among 192 pharmacology receptors/enzymes evaluated.”

“The study is not considered to be a valid assessment of the mutagenicity of durlobactam, since toxicity precluded testing of the strains at doses above 5 μg/plate.”

“Durlobactam was negative for inducing micronuclei in cultured human peripheral blood lymphocytes with or without metabolic activation.”

“Durlobactam did not induce statistically significant increases in micronucleated PCEs at any test article dose up to 2000 mg/kg.”

“Durlobactam did not cause >50% mean inhibitory effect in any of these systems.”