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Aldehyde oxidase is a metabolic enzyme with species differences in expression. SGX523 failed in the clinic due to acute renal failure caused by an insoluble metabolite, which was unexpected due to acceptable safety in rat and dog. The liver humanized PXB-mouse® was employed to assess the suitability of this model for recreating the acute renal effects of SGX523. An integrated approach assessing metabolism, exposure in the target tissue, renal injury biomarkers, and histology is described.
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- The importance of understanding biotransformation mechanisms
Species differences associated with metabolism - How to integrate drug metabolism information within a safety assessment program to ensuring the right species are selected to assess tolerability of drug candidates
- Use of a humanized liver mouse model to retrospectively assess an unanticipated acute renal toxicity
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