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Envigo’s new assessment program can help identify if a drug has possible risk factors associated with hepatotoxicity.
Envigo has introduced hepatotoxicity testing as part of its wider drug development de-risking program. The company noted that one of the major causes of drug withdrawal from the market is due to drug-induced liver injury (DILI).
Envigo’s new assessment program can help identify if a drug has possible risk factors associated with hepatotoxicity. The key tests include covalent binding, reactive metabolite formation, and time-dependent inhibition (TDI) of cytochrome (CYP) enzymes. These assays can be conducted quickly, using small amounts of API. The program can be run in full, using all of its tests, or can be conducted using single assays as required.
“Envigo’s battery of in vitro tests, typically using human cells, enables our customers to determine if a compound carries a DILI liability. A compound that is negative in our in vitro testing program is considerably de-risked from one of the failure factors newly approved drugs face. This allows our customers to make more informed choices as to whether they should progress the compound. The de-risking approach serves to increase patient safety, provides confidence to invest and aids the in/out-licensing of new drugs”, commented Guy Webber, scientific manager of the In Vitro and Drug-Drug Interaction Sciences Group at Envigo, in a press statement.
Brian Burlinson, principal scientist for Safety Assessment at Envigo, commented, “Ultimately, the DILI assessment package forms part of Envigo’s larger de-risking program for new drugs. This broader initiative, driven by the company’s Science and Technology Advisory Group (STAG), comprises DILI assessment, drug-to-drug interactions, genotoxicity, and cardiotoxicity. As our de-risking studies can be carried out very early on, there is time for chemists to re-examine their molecules and assess potential changes that could be made to reduce the DILI liability while maintaining efficacy. Once the molecules are re-engineered, they can then be checked again against the Envigo assays.”