The leading organ-on-chip company (OOC) recently announced that the US Food and Drug Administration (FDA) has expanded their collaboration for the second time. This will allow new research aiming to evaluate multi-organ microphysiological systems (MPS) and their applications using its PhysioMimix Multi-organ System.
The recently passed FDA Modernization Act 2.0 has removed mandatory requirement for animal testing for toxicity making way for these approaches and confirming in vitro alternatives provide enhanced performance in research.
Human drug bioavailability
The system has shown in previous studies to be successful and will now be investigated for improving preclinical estimation of human drug bioavailability compared to standard animal models.
Bioavailability, defined as the fraction of drug reaching the bloodstream, is a critical parameter in orally administered drugs in humans that needs to be understood by drug developers and regulatory agencies.
This critical parameter in during preclinical development is vital as the basis of setting safe and efficacious doses in the clinic.
Accurately predicting the bioavailability of orally administered medicines in humans during preclinical development is crucial, the company says, as it forms the basis for setting safe and efficacious doses in the clinic.
Recapitulating in vitro
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 of collaboration with CN Bio, the FDA has utilized the PhysioMimix Liver model for drug toxicity and metabolism studies resulting in the first co-publication, peer-reviewed article between an MPS provider and a regulator. Within the same year, the FDA and CN Bio broadened their partnership further to explore the potential of the Company’s Lung model across various inhaled drug applications — work on this is still ongoing.
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.”