Speed Adoption of Non-Animal Assays: Murphy

VivoSim Labs executive chairman Keith Murphy says that now that FDA has finalized a rule permitting non-animal methods for drug safety testing, it should move quickly to make a determination that some non-animal methods have already reached a well-qualified state that makes them supportive of the agency’s mandate to cut animal testing. In a statement, he says that the evidence and the agency’s own past logic on animal models already support relying on some human-model results to protect or best serve patients enrolling in clinical studies, giving human-relevant data the same regulatory urgency for certain use cases that it has long given animal studies.

“Several platforms have shown broadly normal liver function using liver cells, alongside clear detection of classic missed liver toxicity examples that were not detected in animals and few false positives,” Murphy said. “For some of those cases, animal models were later backfitted to see a signal but can hardly be expected to be predictive for novel chemical entities. In contrast, 3D primary cell liver models essentially well represent liver biology by so many measures that there’s no logic for ignoring a red flag seen in one. They are built to represent the liver, and when tested in that baseline mode, they reveal liver toxicity for compounds that were previously not detected by other methods. Such a set of results is entirely consistent with readiness for regular utility in assisting FDA in its safety mandate, rather than testing those compounds in humans before screening in such a system. There’s a strong case for FDA pushing to see such data (or equivalent data assuring a higher level of safety) before approving any IND.”

Murphy says that although his company’s liver tissue models are already capable of flagging drug candidates likely to cause liver toxicity, he wants FDA to review more broadly to seek solutions that may be supportive of its goals and not wait for sponsors to qualify them if FDA’s mandates benefit from their use.

With the new rule opening a regulatory pathway for methods like VivoSim’s, Murphy said the next step is for FDA not solely to allow alternative data, but to move quickly to the next logical step: identifying areas and use cases where acting today on new approach methodologies data with the same urgency that it has always applied to animal data would better serve patients and the FDA mandate for safety and efficacy.