The US Food and Drug Administration (FDA) and CN Bio have expanded their collaboration for the second time, with new research aiming to evaluate multi-organ microphysiological systems (MPS) using the PhysioMimix Multi-organ System.
The system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models.
Dr Emily Richardson, Lead Scientist at CN Bio, said: “We are extremely pleased with the FDA’s decision to deepen our research collaboration into the multi-organ space. We are working hard to evidence how our technology can tackle these critical drug development bottlenecks and lead the way towards inclusion of OOC/MPS data within IND submissions.”
Changes to rules for animal testing
Bioavailability is defined as the fraction of drug reaching the bloodstream. Accurately predicting the bioavailability of orally administered medicines in humans during preclinical development is crucial as it forms the basis for setting safe and efficacious doses in the clinic.
Animal models currently dominate when estimating bioavailability, but evidence has shown these models are poor predictors, in part due to inherent physiological and metabolic differences.
Paving the way for approaches such as MPS, the recently passed FDA Modernization Act 2.0 has removed the mandatory requirement for animal testing for toxicity where enhanced performance is proven using in vitro alternatives.
Recreating the in vitro structure of tissues
CN Bio’s PhysioMimix Gut/Liver model recapitulates in vitro the structure and function of these human tissues and their fluidic interaction, for comparing intravenous and oral compound dosing. This model uniquely recreates the combined effect of intestinal permeability and first-pass metabolism by the liver for the prediction of human oral bioavailability.
During the last five years, the FDA has utilised the PhysioMimix Liver model for drug toxicity and metabolism studies and the partnership was broadened to explore the potential of the company’s Lung model across various inhaled drug applications.